With the development of economy and the acceleration of population aging, Prostate cancer (PCa) has presented a situation of high morbidity and mortality worldwide. The recent studies have shown that Chinese patent medicine combined with endocrine therapy in the treatment of prostate cancer not only plays a synergistic role in enhancing the efficacy. This review hopes to adopt meta-analysis to evaluate the efficacy and safety of Chinese patent medicine in the treatment of pain caused by prostate cancer and provides evidence for its application in clinical practice.We will search for PubMed, Cochrane Library, AMED, EMbase, WorldSciNet; Nature, Science online and China Journal Full-text Database (CNKI), China Biomedical Literature CD-ROM Database (CBM), and related randomized controlled trials included in the China Resources Database. The time is limited from the construction of the library to June 2019. We will use the criteria provided by Cochrane 5.1.0 for quality assessment and risk assessment of the included studies, and use the Revman 5.3 and Stata13.0 software for meta-analysis of the effectiveness, recurrence rate, and symptom scores of pain caused by prostate cancer.This systematic review will evaluate the efficacy and safety of Chinese patent medicine for pain caused by prostate cancer. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process Trial.PROSPERO CRD42019131544. The secretion of prostaglandin could accelerate the bone resorption around the tumor. Due to the intense sensibility of the nerve endings, sharp pain hence generate. The American Cancer Society (ACS) released the data of the 2018 us Cancer research, showing that prostate cancer, lung cancer, and colon cancer have become the three major threats for American men. Prostate cancer led the list, accounting for more than a quarter of all new tumors. According to the latest data of the United States in 2016, the most common malignant tumors for men are prostate cancer, colorectal cancer, and melanoma. About 50% of patients were locally advanced when diagnosed, and about 30% had bone metastasis when diagnosed.Prostate cancer is a male malignant tumor disease which has a high prevalence in recent years. Endocrine therapy is always an important part of the prevention and treatment of prostate cancer. Development up to now, no matter what kind of treatment is hard to avoid the side effects of, low testosterone levels can cause such as anemia, cardiovascular side effects,,10 type 2 diabetes, osteoporosis, and many other diseases, severe physical and psychological trauma makes it hard for some patients tolerance, give up the treatments. Modern medical philosophy not only emphasizes to improve the survival rate, but also to improve the quality of life of patients.In April 2015, China's tumor registration center released data reported by 234 registries nationwide, and the incidence of male prostate cancer showed an obvious growth trend.–14 The morbidity of the symptom is about 70% to 90%. According to the statistics which announced by WHO in 2003, there are about 10 million new cancer patients in the world every year, and 300 to 1000 million cancer patients fail to receive timely and effective treatment.,16 The combination of traditional Chinese medicine and endocrine therapy for prostate cancer has become a hot spot in the field of medical research. According to the clinical manifestations of prostate cancer belongs to traditional Chinese medicine “retention of urine” “stranguria” category. Traditional Chinese medicine believes that improper diet, internal injury, external sensation of dampness, and heat are the main causes of prostate cancer. Chinese patent medicine is based on Chinese herbal medicine. Under the guidance of TCM theory, in order to prevent and treat diseases, it is processed into a certain dosage form of traditional Chinese medicine products according to the prescribed prescription and preparation process, which is approved by the State Drug Administration. A class of traditional Chinese medicine preparations. As the most important part of Traditional Chinese medicine, Chinese patent medicines have been widely used in clinical practice as derivatives of Chinese herbal medicine.,20 However, due to the limitation of the size and number of clinical centers, most clinical trials are small samples with low-quality and lack of evidence-based exploration. Besides, the publication of the similar systematic review has not been retrieved in the database. Therefore, this review hopes to adopt meta-analysis to evaluate the efficacy and safety of Chinese patent medicine in the treatment of PE and provide evidence for its application in clinical practice.Cancer pain is one of the most important symptoms in patients who suffer from advanced cancer, and it greatly deteriorate the physical and psychological health, meanwhile, the quality of life of patients.2This systematic review protocol has been registered on PROSPERO as CRD42019131544. The protocol follows the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) statement guidelines. We will describe the changes in our full review if needed.2.12.1.1Take Chinese patent medicine combined with other effective interventions as main treatment, including randomized controlled trials of the control group. Language is limited in Chinese and English. Non-randomized controlled trials, quasi-randomized controlled trials, case series, case reports, and crossover studies will be excluded.2.1.2Male patients who were diagnosed with prostate cancer will be included, the type of the disease includes adenocarcinoma (adenocarcinoma), ductal adenocarcinoma, urothelial carcinoma, squamous cell carcinoma, and adenosquamous carcinoma. Meanwhile, the patients who were recruited should have the symptom of pain caused by prostate cancer, including bone pain caused by bone metastasis. However, the patients who suffer from pain caused by other factors would be excluded. Patients who suffer from cognition impairment and other severe mental illness will also be excluded. In addition, the inclusion criteria will not be restricted by region, country, nation and origin.2.1.32.1.3.1Chinese patent medicines or the combined western medicine are used as experimental interventions. Other traditional Chinese medicine treatments such as intravenous medication, acupuncture, and massage will be limited.2.1.3.2As for the control interventions, who accepted simple western medicine can be used as a control intervention or did not get any treatment as a blank control would be adopted. However, once they had accepted the therapy of TCM, the trials will be rejected.2.1.42.1.4.1Adopting NRS  of pain criteria as the main evaluation, the specific division: Painless 0 points; mild pain 1 to 3 points; moderate pain 4 to 6 points; severe pain 7 to 9 points; severe pain 10 points, 0 to 10 points representing the patient's pain level. Significantly effective: the patient's pain level is reduced by at least two or three levels, or the patient is painless; Effective: The patient's pain level is reduced by one grade or the patient presents moderate and mild pain; Invalid: The patient's pain does not have any relief, and there is even a tendency to aggravate.2.1.4.21.International prostate symptom score (IPSS), the patient self-evaluation form;2.Quality of life scores for patients with prostate cancer before and after treatment (PRSSQOL): A scale, designed by the University of California, USA, to evaluate the condition and living quality of patients who suffer from advanced, hormone-insensitive prostate cancer. It specifically includes nine aspects: Physical strength, pain, fatigue, appetite, family/marriage, constipation, mood, defecation, and overall feelings. Each item is calculated with 100 points, and the lower the score, the worse the situation.2.2We will Search PubMed, Cochrane Library, AMED, EMbase, WorldSciNet; Nature, Science online and China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM), China Resources Database. The temporal interval is limited from the time that the databases created to June 2019, and the combination of keyword and free word retrieval is adopted. The search terms include “Chinese patent medicine,” “proprietary Chinese medicine,” “prostate cancer,” “prostate cancer,” “pain,” “Random Control.” The complete PubMed search strategy is shown in Table 2.32.3.1Initial evaluations were performed independently by two investigators through filtrating the titles and abstracts of each documents in the Endnote database, eliminating duplicates and documents that were clearly inconsistent with the study. After the preliminary assessment, in order to screen out eligible trials, the full text of the selected literature would be evaluated, which mainly aims at whether there were problems just like uncontrolled studies, no randomization, inconsistent assessment criteria, and similar data. When the two researchers could not reach a consensus, the third judge would make the final judgment.2.3.2There will be two investigators independently extract information from the included literature, mainly contents: Author (year), sample size, disease stage, patient age, intervention factors, control factors, intervention time, observation index, NRS score, symptoms Ratings, quality of life scores, etc. The extracted literature data is filled in a unified data statistics table.2.3.3Cochrane Intervention System Evaluation Manual, it is divided into low risk, high risk, and unclear.Two investigators independently assess the quality of the included literature by using the Cochrane Collaboration's bias risk assessment tool. The assessment includes: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other possible biases. According to the relevant standards in the 2.3.4In the event of data loss during the screening and extraction of literature data, primarily, we would actively look for the cause of the loss, and then we would contact the experimental research author by telephone, mail, etc. to retrieve the lost data. If the loss could not be retrieved, we will only extract and analyze the useful data, and the situation would be indicated.2.3.5P < .05. Heterogeneity test would be analyzed by using chi-square test. When P ≥ .1, the difference was considered to be not statistically significant. When P < .1, I2 > 50%, the random effect model would be used, as for the other situation, the fixed effect model would be adopted. For studies that provide baseline and post-treatment data, we will estimate the change values by the method recommended by Cochrane. The details of selection process will be shown in the PRISMA flow chart  or odds ratio (OR) and 95% CI. As for the continuous variables, we select weighted mean difference (WMD) or standard mean difference (SMD) and 95% CI, the difference would be statistically significant when 2.3.6If there is significant heterogeneity between a group of studies, we will explore the reasons for the existence of heterogeneity from various aspects, such as the characteristics of the subjects and the degree of variation of the interventions. Necessarily, sensitivity analysis or subgroup analysis would be adopted to explain the heterogeneity.2.3.7The forest map and funnel plot would be drawn and analyzed by Rev Man5.3 software, and the funnel plot would be used to analyse the potential publication bias.2.3.8The quality of evidence for the main outcomes will also be assessed with the GRADE approach. The evaluation included bias risk; heterogeneity; indirectness; imprecision; publication bias. And each level of evidence will be made “very low,” “low,” erate,” or “high” judgment.3,22 Recent years have witnessed an increase on the study of treating cancer pain, vast researches have indicated that analgesics have great efficiency in ameliorating pain, but the pesticide effects are short, and there are kinds of adverse reaction, such as kidney damage, liver damage, cardiovascular and cerebrovascular damage, digestive disease, etc.,24 Generally speaking, numerous patients who suffer from cancer could not gain satisfied control effect. Moreover, these patients need long-term use of analgesic drugs to ameliorate pain, which also directly increase the cost of therapy for patients.At present, pain has been the fifth vital sign, which together with respiration, blood pressure, pulse, and body temperature. In 1996, the American Pain Association (APA) first proposed the concept of pain and its control, which indicated that an effective pain relief program for patients is a basic requirement for clinical medical work. It has been a difficult problem to the treatment of pain caused by prostate cancer and its bone metastasis in the middle and advantaged stage, which has belonged to refractory cancer pain. Chinese patent medicine is based on traditional Chinese medicine. Under the guidance of traditional Chinese medicine theory, in order to prevent and treat diseases, it is processed into a certain dosage form of traditional Chinese medicine products according to the prescribed prescription and preparation process, which is approved by the State Drug Administration. A class of traditional Chinese medicine preparations. As the most important part of Traditional Chinese medicine, Chinese patent medicines have been widely used in clinical practice as derivatives of Chinese herbal medicine and the recent studies have shown that the therapy could ameliorate the pain cause by prostate cancer to some extent and improve the quality of the life.Traditional Chinese medicine, has been proved that it is a safe, feasible, and effective treatment. The clinical operation and theory of TCM have been inherited and carried forward by the majority of clinicians, especially in the treatment of pain. This therapy could ameliorate vast kinds of pain efficiently, and there is no adverse reaction which could insure the security.As far as we know, there has not made any comparison of the effectiveness of Chinese patent medicines in the treatment of prostate cancer pain. Therefore, we will use systematic review and meta-analysis to evaluate the efficacy and safety of Chinese patent medicines for the treatment of pain caused by prostate cancer. We expect that the review could provide a basis for Chinese patent medicines treatment of pain caused by prostate cancer and offer more and better options for the treatment to patients.Conceptualization: Hong Li.Data curation: Xu-dong Yu.Funding acquisition: Xiaoyong Gong, Xu-dong Yu.Methodology: Xiaoyong Gong, Ji-sheng Wang.Project administration: Yuan-yuan Li.Resources: Ji-sheng Wang, Yuan-yuan Li, Yi Lei.Software: Xu-dong Yu, Rui-jia Liu, Li-yuan Chu, Yi Lei.Supervision: Rui-jia Liu.Validation: Rui-jia Liu, Hong Li.Visualization: Hong Li.Writing – original draft: Li-yuan Chu.


Our study suggests the more successful balloon adhesiolysis procedures for multiple target lesions are performed, the better clinical outcome can be expected at least 6 months after treatment.Combined balloon decompression and epidural adhesiolysis has been reported to be effective in refractory lumbar spinal stenosis. Many cases of intractable stenosis have symptom-related multiple target sites for interventional treatment. In this situation it may not be possible to perform balloon adhesiolysis, or even only epidural adhesiolysis, for all target sites. Therefore, this multicenter prospective observational study aimed to evaluate the relationship of successful ballooning rate for multiple target sites with clinical outcome. Based on the ballooning success rate of multiple target sites, the patients were divided into three groups: below 50%, 50–85%, and above 85% ballooning. A greater ballooning success rate for multiple target sites provided a more decreased pain intensity and improved functional status in patients with chronic refractory lumbar spinal stenosis, and the improvement was maintained for 6 months. The estimated proportions of successful responders according to a multidimensional approach in the below 50%, 50–85%, and above 85% balloon success groups at 6 months after the procedure were 0.292, 0.468, and 0.507, respectively ( Low back pain and/or radiating leg pain is a common medical and social condition in the general population ,2,3. Var®, JUVENUI, Seongnam, Korea) was designed with an inflatable balloon attached to the end of the catheter tip [The initial management of lumbar radicular pain and/or low back pain generally involves conservative treatment such as physiotherapy, medication, and epidural injections ,8. Epidueter tip . In preveter tip , and impeter tip . HoweverIn this study, we aimed to investigate the relationship of successful balloon adhesiolysis rate for multiple targets with clinical outcomes. Moreover, to maximize the generalizability of the findings and the possibility of external validation, patients in spine specialty hospitals as well as tertiary referral centers were included in the study.This was a prospective, multicenter study conducted at the pain management clinics of five centers in the Republic of Korea . The study protocol was reviewed by the ethics committees or investigational review boards at each participating site. This study was registered in the Clinical Research Information Service in Republic of Korea (KCT 0002280).Between July 2015 and April 2018, patients with chronic lumbar spinal stenosis, aged 20 years or older, suffering of intractable low back pain and/or lumbar radicular leg pain for more than 3 months were examined to ascertain their eligibility. A comprehensive assessment of medical history and physical examination were done on every patient to exclude a confounding disease as another cause of pain. To ascertain the diagnosis of spinal stenosis and determine the grade or level of spinal stenosis, lumbar magnetic resonance imaging (MRI) was performed on all patients. The degree of spinal stenosis was analyzed on the basis of MRI findings, as described in a previous study . The incAll procedures in the present study were done based in an outpatient setting. There were no sedatives or premedication administered prior to procedure. All procedures were performed under fluoroscopic guidance. The position of each patient was the prone position and the pillow was placed under the abdomen to minimize lumbar lordosis. After sterile preparation before the procedure, local anesthetic was infiltrated into the skin and soft tissue. A 10-gauge guide needle was specially designed for preventing the various types of potential damage of a catheter during catheter manipulation. The guide needle was gently introduced via the sacral hiatus under fluoroscopic guidance by experts with experience of more than 500 procedures. Consequently, about 8 mL of diluted contrast medium  was injected using the guide needle. The epidural space was confirmed by the spread of diluted contrast medium using fluoroscopy. The diluted contrast medium was prepared by mixing 4 mL of pure contrast medium, 4 mL of 1% lidocaine, and 1500 I.U. of hyaluronidase. By examining the contrast flow, filling defects or intravascular injections were identified. In the case of intravascular injection, the needle was repositioned. After suitable identification via an epidurogram of the target areas, a ZiNeu catheter was advanced via the guide needle to the filling defects or the sites of suspicious cause of pain, as determined based on both MRI findings and comprehensive assessment of symptoms before the procedure . At the At every instance of epidural adhesiolysis and balloon decompression to each target site, 1 mL of contrast was injected to exclude subarachnoid or intravascular spread. Moreover, the ballooning process at each target site was recorded as successful if ballooning was adequately performed with enough dye spread, and as failed otherwise. The rate of successful balloon adhesiolysis was defined as the number of successful ballooning sites divided by the number of target lesions determined prior to balloon adhesiolysis . There wThen, 10 mL of 0.2% ropivacaine with 5 mg of dexamethasone was divided and injected separately at each target site. A Perifix epidural catheter  was kept at the main lesion via the ZiNeu catheter lumen after the procedure had ended. In a recovery room, 2 mL of lidocaine was injected via the Perifix catheter to exclude the intrathecal injection. After 10 to 15 min of observation, 4 mL of 10% hypertonic saline was administered using the Perifix catheter. The patient was discharged from the outpatient surgery center with a Perifix catheter, and re-visited the outpatient clinic the following day. The same drug administered on the day of the procedure  was injected through a Perifix catheter on the second day of the procedure. After the drugs were administered, the catheter was removed. In case of suspected complications, such as a dura matter puncture, subdural injection, or vascular injection, the procedure was immediately stopped and recorded. Thereafter, the patient was transferred to a recovery room and a neurologic examination was performed. After bed rest for a short duration and confirmation of normal neurologic examination findings, the patient was discharged. The baseline characteristics of all study subjects were analyzed. Outcome assessments were conducted at baseline, and at 1, 3, and 6 months after the balloon adhesiolysis. Before the procedure was performed, all participants were instructed and evaluated on an 11-point NRS from 0 (no pain) to 10 (worst possible pain) to determine the intensity of both leg and lower back pain; the Korean version 10-item Oswestry disability index (ODI) questionnaire  to determine physical functional status; and the Beck depression inventory to assess emotional status. The medication quantification scale III (MQS) was also measured to assess the changes in the usage of medication . The gloA multidimensional approach was used to analyze the study outcomes: the primary outcome was the number of patients with a successful response after balloon adhesiolysis at each follow-up. A successful responder was defined according to previous studies, with some modifications, as: 1) 50% (or ≥4 point) decrease of NRS from baseline, no increase from baseline ODI and MQS, and ≥4 points on the GPE scale; or 2) ≥30% (or ≥2-point) decrease of NRS from baseline together with any one of the following criteria: ≥30% (or ≥10 point) decrease in ODI from baseline, or ≥5 points on the GPE scale, or no increase from the baseline MQS. In addition, the NRS, ODI, MQS, and GPE scales of satisfaction were measured at 1, 3, and 6 after balloon adhesiolysis. The decreases in pain intensity, ODI, and MQS compared with baseline at each follow-up period were also recorded. Possible complications associated with the procedure were reported, and all side effects were further evaluated at follow-up visits. Patients were told to continue their previously prescribed analgesic medications if possible. Prior to participate in this study, all participants were told not to change any prescribed medications for the first month after the procedure, and they understood and agreed to these guidelines. The prescribed doses of each analgesic were then titrated based on the NRS at each follow-up period in the outpatient visit except opioids. Patients who needed to increase the dosage of analgesics, or who wanted other treatments, were regarded as treatment failures after the follow-up visit and recorded as having dropped out of the study. Patients who were lost to follow-up, prescribed an increased dose of opioid, performed other interventions, or were treated by surgery were also recorded to be treatment failures at that time-point. Each patient with treatment failure was defined as a non-responder at each follow-up visit.p-value < 0.05 was considered to indicate a statistically significant difference.Categorical variables are expressed as numbers and percentages. Continuous variables are expressed as means with standard deviation (SD), 95% confidence intervals (CI), or medians with the interquartile range (IQR), as appropriate. To compare demographic data between the three groups, the chi-square test or Fisher exact test was used to assess categorical data, as appropriate. One-way ANOVA or Kruskal–Wallis tests were used to analyze numerical data, as appropriate. All data were measured and analyzed on an intent-to-treat basis, regardless of follow-up loss or withdrawal from the study. Because of data loss resulting from drop-outs, a linear mixed effect model (LMEM) was used to compare changes within and between groups in terms of continuous variables  at baseline and 1, 3, and 6 months after balloon adhesiolysis. To compare repeated data of successful responders (binary outcome) among groups, a generalized estimating equation was used. Data were analyzed using the Statistical Package for the Social Sciences  or SAS version 9.3 . A two-tailed A series of 454 patients who had been diagnosed with lumbar spinal stenosis between July 2015 and April 2018 were screened for eligibility to participate in this study. These patients presented with chronic lumbar radicular pain, with or without lower back pain. Among these patients, 156 did not meet inclusion criteria, 21 declined to participate in the study or did not visit again, 1 received another procedure, and 1 experienced relief from the symptoms. Ultimately, 275 patients received the intervention . The basp = 0.003). Compared with the patients in the above 85% and 50–85% success groups, those in the below 50% success group had lower body mass index (24.2 (2.9) vs. 24.8 (2.9) vs. 23.2 (4.1), respectively, p = 0.019). There was no significant difference in demographic data other than age and body mass index between the three groups . The p-value of the interaction between groups and time for successful responders was 0.096 . The obsp < 0.001), and the group effect for GPES was not (p = 0.346). The interaction between group and time for GPES was statistically significant (p = 0.010). The estimated mean changes from baseline in the NRS of back and leg pain, and ODI functional status over the 6 months of follow-up, are shown in Cumulative lists and rates of the observed complications during the decompression and adhesiolysis with an inflatable balloon catheter are shown in In the present study, we analyzed the relationship of successful ballooning rate for total target sites with clinical outcomes such as back and leg pain, and functional capacity based on ODI. Our study suggests that the more successful balloon adhesiolysis procedures for multiple target lesions that are performed, the better the clinical outcome that may be expected at least 6 months after treatment. In contrast with the presence of a single lesion , the presence of many potential lesions, as observed in elderly patients with degenerative spinal disease, is often associated with pain or functional disability ,21,25. IThe efficacy of percutaneous epidural adhesiolysis in chronic low back pain refractory to conservative therapies has been relatively well investigated ,11. VariThis study has several potential limitations. The definition of successful responder could conceivably be criticized, as different results might have been obtained if the definition had been changed. Therefore, the definition of successful responder was determined according to previous reports and recommendations ,30,31,32The balloon decompression and epidural adhesiolysis with a ZiNeu catheter can lead to significant pain relief and functional improvement lasting at least 6 months in patients with chronic refractory spinal stenosis. Compared with balloon success rates below 50% for multiple target sites, success rates greater than 50% may lead to more significant improvements in back pain, leg pain, and functional capacity for at least 6 months.


Groin injury, sportsman’s groin and inguinal disruption (ID) refer to a diffuse chronic groin pain syndrome that has significant impact on athletes and is often unresponsive to conservative management. The ID aetiology is poorly understood but may involve weakness of the inguinal ligament attachments or the posterior inguinal canal wall or the tendons of adductor longus and rectus abdominis. We discuss the literature in which the inguinal ligament was directly targeted for ID management in athletic populations. Secondarily, we discuss the anatomical reclassification of the inguinal ligament to a tendon based on the above information.This was a qualitative review of the published literature, in English, from January 2007 to February 2017.Five research papers, including 264 patients, were appraised. In patients with ID, tears were identified in the inguinal ligament, and to relieve pain, the surgical treatment of the ligament by tenotomy was shown to be beneficial. Techniques such as radiofrequency denervation involving the inguinal ligament and ilioinguinal nerve were also shown to relieve symptoms in athletes.This qualitative review has specifically focused on the literature directly targeting the inguinal ligament in ID which is a relatively unexplored management approach. When treated as a tendon, the inguinal ligament appears to be an appropriate ID therapeutic target. Integrated studies and randomised clinical trials will promote a better understanding of the role of the inguinal ligament and its tendinous properties in ID and provide a foundation for evidence-based management of chronic groin pain in athletes. The inguinal ligament was first described by Fallopius in 1562 with its structure being further delineated by François Poupart in 1705 . Doyle sGroin injuries account for 2–5% of all sport-related injuries , with anInguinal hernias may present similar to ID, with pain radiating towards the groin which is worsened by raised intraabdominal pressure. Typically, indirect hernias occur in children under one and direct occur in adults over 45 years of age , cohortsThe primary aim of this review was to discuss the published literature in which the inguinal ligament has been directly targeted as a tendon for therapeutic purposes in the management of ID amongst athletic populations. A secondary aim was to discuss the anatomical reclassification of the inguinal ligament to a tendon based on the above information and drawing from structural and functional evidence supporting this argument. The hypothesis was that direct inguinal ligament tenotomy , 19 or rOvid Medline, PubMed, Embase, Cochrane Library , SCOPUS (1960 onwards) and Web of Science (core collection) were searched for full-text primary research papers published in the English language from January 2007 to February 2017  directly targeted the inguinal ligament for ID management in athletes Tables . The fir9% male dGilmore retrospectively assessed clinical information from 65 male professional association footballers . All patients had chronic pain in the inguinal region, without any visible or palpable signs. In all patients, the conjoint tendon was surgically repaired and then approximated to the inguinal ligament. This intervention was considered successful in 63 of 65 (97%) based on the outcomes of return to training within 3 weeks and return to competitive play within 10 weeks. The average return to play time was 6 weeks Table  8]..8].Lloyd et al. retrospectively assessed the case notes of 48 patients , of whom 37 (77%) were amateur athletes and 11 (23%) were manual labourers, who underwent laparoscopic TAPP repair with inguinal ligament tenotomy. All patients suffered tenderness over the inguinal ligament. There were significant improvements in pain severity and functional limitation and 92% of 28 participants, who completed prospective questionnaire, had a median return to play of 28 days’ post-operation , 37 (51%) being professional athletes, who underwent laparoscopic TAPP repair with inguinal ligament tenotomy. All patients had symptoms suggestive of inguinal ligament pathology. 97% reported an improvement in symptoms, with 73% being free of symptoms. Median return to competitive sports was 28 days  being professional athletes, who were randomly assigned to two groups of 18. Group 1 underwent RFD, and group 2 were treated with local anaesthetic (bupivacaine) combined with corticosteroid (triamcinolone) injection. A further 10 participants who underwent previous unsuccessful surgery were assigned to group 3 that underwent RFD. In group 1, RFD significantly improved pain severity scores from baseline in rest and during activity up to 6 months. Local anaesthetic and corticosteroid resulted in improved pain scores at 1-week post-treatment, however, this effect was transient and subsequent measures did not differ significantly from baseline. The non-randomised group, who underwent RFD, also showed significant and consistent improvement in pain scores from baseline to 6 months’ post-treatment  male) and found significant improvements in pain scores from baseline to 9 months’ post-treatment. However, one patient received no pain relief following two treatments, although this patient had no evidence of pathology on MRI. 24 of the 32 participants commenced physiotherapy within days of treatment, although the number of days was not specified  and RFD was performed on 60 patients.Current management begins conservatively with physiotherapy to improve pelvic stability  that maySurgical interventions may be performed open or laparoscopically using a polypropylene mesh in either TAPP or totally extraperitoneal (TEP) repair. A non-randomised study has shown that minimally invasive techniques reduce return to play time when compared to open approaches . The ratIn the study by Gilmore, all 65 football players were described as having ‘Gilmore’s Groin’, experiencing chronic inguinal region pain which was made worse by actions such as sprinting, kicking, coughing and sneezing . In LloyGilmore managed patients by surgically repairing the inguinal ligament with plication to the conjoint tendon, with a focus on restoration of normal anatomy involving a six-layered surgical technique . The autFor the patients with ID who did not undergo surgery, the results of the studies by Comin et al. and Masala et al. demonstrated that neuromodulation by RFD is effective in reducing pain. Masala et al. show that denervation around the groin area is effective in the short term , whilst As recommended in the 2014 multidisciplinary consensus, we believe that athletes with unexplained groin pain causing functional limitation should undergo an initial treatment period involving 2 months of tailored physiotherapy, prehabilitation, analgesia and rest, utilising a multidisciplinary approach . Those wThe pubic bone is important in ID as the site of attachment of several structures which, if damaged, may precipitate a sport injury. From the PT, the inguinal ligament continues as the pre-pubic aponeurotic complex (P-PAC) which connects to the underlying fibrocartilaginous disk of the pubic symphysis. In addition, the pubic bone receives the tendons of adductor longus and rectus abdominis. It has also been suggested that ID is the result of a weakness or tear in the posterior wall of the inguinal canal . AnotherGilmore describes a pathophysiological mechanism of ID comprising a torn external oblique aponeurosis causing a dilated superficial inguinal ring, in addition to dehiscence between the inguinal ligament and a torn conjoint tendon  . It has One might argue that the taxonomy—tendon versus ligament—of the inguinal ligament is purely semantic as they are broadly similar types of connective tissue. Macroscopically, these are classified according to their connections; either bone to bone for ligaments or skeletal muscle to bone for tendons. However, this rudimentary logic cannot be applied to the inguinal ligament, which connects the ASIS to PT whilst arising from the aponeurosis of the external oblique. Another consideration is that the purpose of a musculoskeletal ligament is to stabilise a joint between two bones. Although separate in the pre-adolescent, the ileum and pubis are fused as the singular hip bone in the mature adult. Resultantly, the inguinal ligament has no joint to stabilise per se.Although ligaments and tendons comprised of the same basic components, the exact proportion and arrangement of each of these varies histologically according to the mechanical and functional needs of structures . Amiel eAlthough there is literature relating to the treatment of ID in elite sportspeople, particularly utilising mesh repair procedures and adductor longus tenotomy , 21, 26,Reported differences in the discussed studies could be due to the intervention allocation itself rather than the actual intervention. As such, outcome data for interventions performed by Lloyd et al. and Mann et al. are only applicable to patients with symptoms and characteristics similar to those within these studies. This review has also highlighted widespread heterogeneity of outcome reporting. Currently, there is no consensus on the most appropriate outcome measures for athletic groin pain. Outcomes most commonly reported are on pain severity by visual analogue scale, return to play time and return to play rate. There is, however, an alternative patient-reported outcome questionnaire based on assessment of pain, symptoms and function which has been validated in young to middle-aged patients . Our vieThis review has provided pooled evidence supporting the concept that targeting of the inguinal ligament, as a tendon, is beneficial in terms of reducing symptoms and improving return to play time in athletes experiencing ID. We support the 2014 multidisciplinary consensus, according to which athletes with clinical symptoms or investigative findings suggestive of ID should undergo a period of physiotherapy, prehabilitation, analgesia and rest during the diagnostic process with surgery considered if symptoms persist beyond 2–3 months. Surgical interventions should be tailored to each patient’s clinical presentation, investigative findings and hence likely underlying pathology. The development and validation of a reporting tool for patient outcomes will also allow for standardisation and undoubtedly aid the above process. Clinically integrated research studies are also needed to delineate the precise role of the inguinal ligament and its tendinous properties in ID. Future large scale randomised clinical trials should evaluate laparoscopic TAPP with and without inguinal ligament tenotomy to provide high quality evidence-based guidelines for the management of chronic groin pain in athletes.


Based on the new international guidelines for groin hernia management, there is no one surgical technique that is suited to all patient characteristics and diagnostic findings. Therefore, a tailored approach should be used. Here, a distinction must be made between primary unilateral inguinal hernia in men and in women, bilateral inguinal hernia, scrotal inguinal hernia, inguinal hernia following pelvic and lower abdominal procedures, patients with severe cardiopulmonary complications, recurrent inguinal hernias and incarcerated inguinal and femoral hernias. This paper now explores the relevant studies on TEP for elective primary unilateral inguinal hernia in men, which constitutes the most common indication for repair.A systematic search of the available literature was performed in February 2019 using Medline, PubMed, Scopus, Embase, Springer Link and the Cochrane Library. Only meta-analyses, systematic reviews, RCTs and comparative registry studies were considered. 117 publications were identified as relevant.RCTs and comparative registry analyses demonstrated the advantages of TEP with regard to postoperative complications, complication-related reoperations, and postoperative and chronic pain compared with Lichtenstein repair for elective primary unilateral inguinal hernia repair in men. No relevant differences were found compared with TAPP. Mesh fixation is not needed in TEP, but heavyweight meshes result in a lower recurrence rate. Extraperitoneal bupivacaine analgesia vs placebo does not demonstrate any advantages, but drainage is advantageous for seroma prophylaxis. The risk of chronic pain is negatively influenced by small defects, younger patient age, preoperative pain, higher BMI, postoperative complications, higher ASA score and risk factors.For the subgroup of elective primary unilateral inguinal hernia in men, accounting for a proportion of less than 50% of the total collective, advantages were identified for TEP compared with open Lichtenstein repair but not versus TAPP. Using evidence-based guidelines and recommendations, the international hernia societies are trying to improve the quality of hernia surgery through standardization of treatment –6. The mAccordingly, the guidelines urgently recommend that surgeons adopt a tailored approach for inguinal hernia repair –8. In doThe data available for elective primary unilateral inguinal hernia repair in men with the TEP technique are now explored in the following.A systematic search of the available literature was performed in February 2019 using Medline, PubMed, Scopus, Embase, Springer Link and the Cochrane Library as well as a search of relevant journals and reference lists. The following search terms were used: “total extraperitoneal patchplasty”, “TEP”, “TEP hernia”, “Inguinal hernia and TEP”. The titles and abstracts of 688 publications were screened  and comparative registry studies.The present analysis identified 117 publications as relevant for this review. A systematic presentation and synthesis of the characteristics and findings of the included studies have been made in accordance with the Prisma guidelines .There are already two meta-analyses focusing exclusively on the comparison of the totally extraperitoneal patch plasty (TEP) with the Lichtenstein technique.p = 0.09), nor was there any significant effect on the number of patients with recurrences in a random-effects model , and the TEP technique may or may not be associated with less severe adverse events . Trial sequential analysis showed that the required information size was far from reached for important patient outcomes. The authors concluded that TEP versus Lichtenstein for inguinal hernia repair has been evaluated by 13 trials with high risk of bias. The review with meta-analyses, trial sequential analyses and error matrix approach shows no conclusive evidence of a difference between TEP and Lichtenstein on the primary outcomes chronic pain, recurrences and severe adverse events.In a systematic review with meta-analysis and trial sequential analyses of randomized clinical trials, 5404 patients from 13 studies were included . There wThe meta-analysis evaluated the following RCTs: Andersson , Colak , Eklund Analysis of the inclusion and exclusion criteria showed for the studies –25, 27 tAnother meta-analysis of randomized controlled trials comparing Lichtenstein and TEP for treatment of inguinal hernias included 13 RCTs with 3279 patients . That meIf one compares the two meta-analyses on the basis of the included studies, one notes that only six studies , 31, 32 As pointed out above, to explore the question of comparing TEP vs Lichtenstein for primary unilateral inguinal hernia repair in men, these studies that included women, bilateral hernias and recurrent hernias had to be excluded , 33–37.Therefore, from the two meta-analyses in addition to the aforementioned studies by Eklund , Gokalp Other studies  which could potentially lend themselves to answering this key question included one cost analysis contained in the Eklund study . In addiThe details and outcome of studies (1096 TEP procedures vs 1141 Lichtenstein procedures) consulted for answering the questions are listed in Table p < 0.001), consumed fewer analgesics on days 1, 2, 3, 5 and 7 (p < 0.001), had a shorter period of sick leave  and a shorter time to resumption of normal physical activity .In the study by Eklund et al. , a totaln = 100) or open Lichtenstein (n = 100) hernioplasty under general anesthesia. The mean operating time for TEP (50 ± 13.2 min) was significantly shorter than for open Lichtenstein hernioplasty (58 ± 17.6 min) (p < 0.001). The postoperative complication rate was 15% for both procedures. The pain score at rest was significantly lower in the TEP group than in the open group on postoperative days 0,1,4,5 and 6. On average, patients returned to work 8.6 days after TEP and 14 days after Lichtenstein hernioplasty (p = 0.006). Postoperative recovery was comparable between the two groups.In the study by Lau et al. , a totaln = 22) or a Lichtenstein operation (n = 23). The operating time was shorter in the Lichtenstein group . The mean daily pain score for 2 weeks was significantly lower for TEP (p < 0.05). There was no difference in the need for oral analgesics (8 vs 11 capsules) or in the duration of analgesia (4 vs 5 days). Return to normal life in the TEP group was significantly earlier  as well as return to work .In the study by Heikkinen et al. , 45 empln = 25) or Lichtenstein (n = 25).In the study by Hamza et al. , which ip < 0.001). Postoperative pain on days 1 and 2 was significantly higher in patients with Lichtenstein repair (p = 0.002 and 0.020). TEP operations were associated with significantly faster return to normal domestic activities  and to work .The operating time for TEP, at 77.4 ± 43.21 min, was significantly longer than for Lichtenstein repair at 34.21 ± 23.5 min (n = 194) or Lichtenstein under local anesthesia (n = 195). One patient in the TEP group and four in the Lichtenstein group were excluded due to protocol violation. Men in the TEP group had less risk of pain affecting daily activities . Pain prevented participation in sporting activities less frequently after TEP . Twenty-nine patients (7.7%) reported sick leave exceeding 1 week due to groin pain, with no difference between the treatment groups. 6 weeks after surgery any pain in the operated groin was reported after TEP in 30.9% vs Lichtenstein in 46.5% (p = 0.002) of cases.In the study by Dahlstrand et al. , a totalThe authors concluded that patients who underwent the TEP procedure suffered less pain 6 weeks after inguinal hernia repair than those who underwent Lichtenstein with local anesthesia. Groin pain after Lichtenstein with local anesthesia affected the patients’ ability to perform strenuous activities such as sports more than TEP patients.p = 0.002) and total operating room time  were significantly longer in the TEP group. There was no significant difference in the postoperative complication rate . Postoperative pain scores in the TEP group were lower than the scores in the Lichtenstein group, but the difference was not statistically significant. There was significantly more use of analgesics and higher C-reactive protein levels in the Lichtenstein group. Quality of life and patient satisfaction were similar in both groups. The authors concluded that Lichtenstein under local anesthesia was as good as TEP under general anesthesia.In the study by Dhankhar et al. , a totaln = 61) or Lichtenstein (n = 62) inguinal hernia repair. The patients were followed up for a median of 18 months. In terms of postoperative pain, analgesic requirements, complications, hospital stay and duration of limitation of normal daily activities, there was no significant differences between the two groups. Operating time for TEP was 16 min longer than for Lichtenstein open tension-free technique. Return to work was shorter in patients with TEP.In the study by Gokalp et al. , 123 menOnly four out of seven RCTs comparing TEP vs Lichtenstein for unilateral primary inguinal hernia in male patients reported the recurrence and chronic pain rates.In the study by Heikkinen et al. , there wp = 0.032).In the Lau study , none ofn = 21) in the TEP group and 1.2% (n = 7) in the Lichtenstein group (p = 0.008). There was wide variability in the incidence of recurrence between different surgeons and hospitals for the TEP method. The 5-year recurrence rate ranged from 0% to 32% (0/55–7/22) for the individual surgeons and from 0% to 13.5% (0/101–7/52) for the different hospitals. This was not the case for the Lichtenstein repair, where the corresponding rates ranged from 0% to 4.3% (0/46–1/23) and from 0% to 2.4% (0/64–2/86), respectively. Three out of 22 surgeons in the TEP group were responsible for 57% (12/21) of all recurrences, one of them for 33% (7/21). This surgeon operated on 25 patients, 22 of whom completed follow-up. His results diverged greatly from those of the other surgeons in the TEP group when tested for heterogeneity (p < 0.001). If this surgeon is excluded from the calculation, the cumulative recurrence rate in the TEP group would be 2.4%, and the difference in recurrence rate between the groups would be nonsignificant (p = 0.109).In the study by Eklund et al.  at a medp < 0.001).The total incidence of chronic pain in the study by Eklund et al.  was 11.0In the study by Gokalp et al. , only onOnly in two studies was cost analysis performed. In the study by Gokalp et al. , the meap < 0.001). Including costs associated with recurrences and complications, this difference increased to € 795.1 (p < 0.001). Taking community costs into account, the difference decreased by € 503.1–292.0 (p = 0.024).In the study by Eklund et al. , the totIn summary, no differences were observed in the intra- or postoperative complications following primary unilateral inguinal hernia repair in male patients between the TEP and Lichtenstein technique. Clear advantages were observed for the TEP technique in terms of early postoperative pain, analgesic consumption and return to normal daily activities and to work. When the surgeon had sufficient experience of the respective technique, i.e., after overcoming the learning curve, no significant difference was detected in the recurrence rate between the TEP and Lichtenstein operation. Likewise, chronic pain occurred significantly less often after TEP than after Lichtenstein operation. In the three RCTs with at least 100 patients in each arm, the operating time for TEP was either similar to or shorter than for Lichtenstein operation. The direct operative costs for TEP are higher than for the Lichtenstein operation. However, that difference decreases when all community costs are taken into account.Further large RCTs are urgently needed to compare TEP versus Lichtenstein for primary unilateral inguinal hernia in male patients. It must be ensured that, by carefully selecting the participating surgeons, the learning curve has been overcome for the respective surgical technique Table .Table 2Sp < 0.001), pain at rest (p = 0.011), and pain on exertion (p < 0.001) at 1-year follow-up.In a multivariable analysis of data from the Herniamed Registry, 10,555 Lichtenstein operations were compared with 6833 TEP operations for repair of elective primary unilateral inguinal hernia in male patients . TEP wasNo advantages were noted for TEP in terms of the complication-related reoperation rate, recurrence rate or chronic pain rate requiring treatment at 1-year follow-up .In another analysis of data from the Herniamed Registry, propensity score matching was performed to compare 12,564 TEP repairs with 12,564 Lichtenstein operations for patients with comparable characteristics .p = 0.282; OR 1.090 ] or the recurrence rate  at the 1-year follow-up  and EHS I (< 1.5 cm) vs EHS III (> 3 cm)  in TEP demonstrated that small hernia presented a significantly higher risk for development of chronic pain requiring treatment   . Other n< 0.001] .One systematic review investigated the influence of TEP on male infertility . The anaLikewise, another systematic review by Dong  featuredFrom that systematic review, the authors concluded that inguinal hernia repair with mesh in laparoendoscopic technique had no significant effect on male fertility . AlthougSystematic reviews have demonstrated strong evidence of an association between higher volumes and better outcome in surgery .p = 0.023] and pain on exertion  at the 1-year follow-up [A study of data from the Herniamed Registry identified for primary unilateral inguinal hernia repair in men in laparoendoscopic technique significant differences in relation to the annual surgeon volume . Multivaollow-up .That finding was confirmed by a further study for surgeons with > 30 TEP operations per year, albeit that study included a very large proportion of bilateral procedures .Likewise, the study by Aikoye , which aAs the chairman responsible for a Department of General Surgery, first in Hanover and then in Berlin, the author has 20 years’ experience of routine inguinal hernia repair in TEP technique . During Between 2010 and 2018, 3365 hernia patients were treated in the Certified Hernia Center, Department of General Surgery, Vivantes Hospital Berlin, and their data entered into the Herniamed Hernia Registry. These related to 1679 patients with 2166 inguinal hernia repairs, 761 incisional hernias, 375 epigastric hernias, 283 umbilical hernias, 239 hiatal hernias and 28 parastomal hernias. Of the 2166 inguinal hernia repairs, 1000 were performed or assisted with TAPP technique by two senior physicians and 834 with TEP technique, which were all carried out by the author himself or at which he assisted, 291 with Lichtenstein and 41 with other techniques.Of the 834 TEP repairs, only 196 (23.5%) involved elective primary unilateral inguinal hernia repair in men. No intraoperative complications occurred in that subgroup of male patients with unilateral inguinal hernia. In the postoperative phase, there were three cases (1.5%) of secondary bleeding in patients continuing to receive treatment with platelet aggregation inhibitors, two cases of seroma (1.0%) and two (1.0%) of impaired wound healing at a trocar puncture site. The complication-related reoperation rate was 1.0%. This was because of secondary bleeding. At the 1-year follow-up, no patient suffered from chronic pain requiring treatment and there were no recurrences. Pain at rest was reported by 2.0% of patients and pain on exertion by 7.7%. Hence, through standardization of the TEP technique, it is possible to achieve very good perioperative outcomes and low chronic pain and recurrence rates. As the same is proven for the TAPP technique, laparoendoscopic repair is the standard procedure for elective primary unilateral inguinal hernia in men in our hospital.In all guidelines TEP and TAPP as well as the Lichtenstein operation as a mesh procedure are recommended for repair of inguinal hernia –6. HowevA rigorous scientific reduction to subgroups from the entire collective of inguinal hernias not only results in exclusion of several RCTs, but also in a re-evaluation of systematic reviews and meta-analyses. This considerably reduces the total number of studies available for answering key scientific questions. But this would mean that the remaining studies would enable more precise statements to be issued for a specific subgroup of inguinal hernias.In the present analysis of the outcome of elective primary unilateral inguinal hernia repair in men using TEP technique, ten publications , 38–41 fUnlike in the RCTs, registry analyses identified for Lichtenstein repair a significantly higher postoperative complication rate and complication-related reoperation rate in comparison with TEP. This could also be because of no patient selection in the registries compared with the rigorous patient selection in the RCTs. Risk patients are not excluded from registries. Similarly, selection of the participating surgeons is less strict in registries than in RCTs. As regards chronic pain, advantages were identified for TEP compared with Lichtenstein repair in the available RCTs and registry analyses. An overview of the available findings for TEP vs Lichtenstein for elective primary unilateral inguinal hernia in men demonstrated advantages for TEP with regard to postoperative complications, complication-related reoperations, early postoperative pain, return to normal activity and work as well as chronic pain. No difference was found in the recurrence rate. A higher intraoperative complication rate may be expected with TEP.Comparison of TEP vs TAPP did not find any relevant difference , 51, 52 There are no RCTs or registry analyses available for mesh fixation vs non-fixation in TEP for elective primary unilateral inguinal hernia repair in men. But from the findings available for bilateral inguinal hernias it can be concluded that fixation can be dispensed with in elective primary unilateral inguinal hernia repair in men –74.Surprisingly, comparison of lightweight vs heavyweight meshes for elective primary unilateral inguinal hernia repair in men demonstrated an advantage for the heavyweight meshes in terms of a lower recurrence rate –85, withExtraperitoneal bupivacaine analgesia vs placebo did not identify any positive effect following elective primary unilateral inguinal hernia TEP repair and should therefore not be administered –94.None of the risk factors, fixation vs non-fixation, lightweight vs heavyweight mesh or preperitoneal bupivacaine analgesia impacted convalescence after elective primary unilateral inguinal hernia repair in men using TEP technique .For smaller defects, an increased risk of chronic inguinal pain was identified, independently of the surgical technique, following elective primary unilateral inguinal hernia repair in men . Other iWhile there are no studies on male infertility following elective primary unilateral inguinal hernia TEP repair in men, as these are available only for patients operated on for bilateral hernias, the findings for bilateral TEP can be extrapolated to unilateral repair since this involves less dissection , 101–107An annual surgeon volume von ≥ 25 TEP operations for elective primary unilateral inguinal hernia repair in men results in a significant reduction in the risk of recurrence and pain on exertion .In summary, it can be stated that in the future scientific studies aimed at comparison of different surgical techniques and identification of factors influencing the outcome should focus on, as far as possible, homogeneous subgroups of inguinal hernias. The subgroup of elective primary unilateral inguinal hernia in men is best suited to that purpose, since it is the most common type of inguinal hernia, accounting for a proportion of around 50% of the entire collective of inguinal hernias and constituting the standard procedure in inguinal hernia surgery. The present analysis of TEP for this subgroup demonstrates advantages compared with open Lichtenstein repair and comparable findings with the TAPP. Mesh fixation is not needed in TEP, but heavyweight meshes result in a lower recurrence rate. Extraperitoneal bupivacaine analgesia does not demonstrate any advantages for postoperative pain, but drainage appears to reduce the seroma rate. Mesh non-fixation, the use of a heavyweight mesh or preperitoneal bupivacaine analgesia do not have a positive effect on convalescence. The risk of chronic pain following TEP is increased for smaller defects, younger patients, preoperative pain, higher BMI, postoperative complications, higher ASA score and risk factors. TEP was not found to have a negative effect on male infertility. An annual surgeon volume of ≥ 25 TEP repairs results in lower recurrence and pain on exertion rates.


Spinal stenosis is a clinical diagnosis in which the main symptom is pain radiating to the lower extremities, or neurogenic claudication. Radiological spinal stenosis is commonly observed in the population and it is debated whether patients with no lower extremity pain should be labelled as having spinal stenosis. However, these patients is found in the Norwegian Registry for Spine Surgery, the main object of the present study was to compare the clinical outcomes after decompressive surgery in patients with insignificant lower extremity pain, with those with more severe pain.This study is based on data from the Norwegian Registry for Spine Surgery (NORspine). Patients who had decompressive surgery in the period from 7/1–2007 to 11/3–2013 at 31 hospitals were included. The patients was divided into four groups based on preoperative Numeric Rating Scale (NRS)-score for lower extremity pain. Patients in group 1 had insignificant pain, group 2 had mild or moderate pain, group 3 severe pain and group 4 extremely severe pain. The primary outcome was change in the Oswestry Disability Index (ODI). Successfully treated patients were defined as patients reporting at least 30% reduction of baseline ODI, and the number of successfully treated patients in each group were recorded.In total, 3181 patients were eligible; 154 patients in group 1; 753 in group 2; 1766 in group 3; and 528 in group 4. Group 1 had significantly less improvement from baseline in all the clinical scores 12 months after surgery compared to the other groups. However, with a mean reduction of 8 ODI points and 56% of patients showing a reduction of at least 30% in their ODI score, the proportion of patients defined as successfully treated in group 1, was not significantly different from that of other groups.This national register study shows that patients with insignificant lower extremity pain had less improvement in primary and secondary outcome parameters from baseline to follow-up compared to patients with more severe lower extremity pain. Radicular pain in the lower extremities known as neurogenic claudication is considered to be the main symptom of Lumbar Spinal Stenosis (LSS) –3. AccorLow back pain is multifactorial, and several explanations are possible. Radiological findings of lumbar spinal stenosis may be incidental, since a high proportion of radiological lumbar spinal stenosis has been documented in asymptomatic subjects , 9. DomiThe aim of the present study was to investigate whether or not the degree of preoperative lower extremity pain influences the clinical results after decompressive surgery for lumbar spinal stenosis.This cohort study is based on data from the Norwegian Registry for Spine Surgery (NORspine). Patients labeled as having had surgery for lumbar spinal stenosis with midline retaining decompression in the period from 7/1–2007 to 11/3–2013 were included. In this period 31 of the Norwegian hospitals (86%) reported to the register. All patients receive oral and written information among their participation in the registry. They sign a written consent to participate in the registry. The registry protocol was approved by the Norwegian board of ethics, REC Central (2014/98).The patients in this study were divided into four groups based on patient-reported preoperative Numeric Rating Scale (NRS) – a score for lower extremity pain. Patients in group 1 had insignificant lower extremity pain , group 2 had mild or moderate pain , group 3 had severe pain  and group 4 had extreme severe pain (NRS-score = 9 and 10)  grade, perioperative complications, operation method, duration of surgery and hospital stay. Patients were selected for the present study if the surgeon had ticked the registration form for the diagnosis lumbar spinal stenosis  and that midline retaining decompression had been performed .The primary outcome was change in pain-related physical function, assessed by the Norwegian version of the Oswestry Disability Index (ODI) questionnaire, version 2.0 . It contSecondary outcome measures were changes in NRS (from 0 (none) to 10 (worst possible)) for leg and back pain, and health related quality of life measured by the EQ-5D (ranging from − 0.59 to 1).The ODI, NRS pain scales, and EQ-5D have shown good validity and reliability, and the Norwegian versions of these instruments have shown good psychometric properties –24.Descriptive statistics for baseline characteristics were performed, as well as for clinical outcomes. Frequencies were used for categorical variables, whereas mean and standard deviations were used for continuous variables. To assess differences in distributions across the four patient groups, the standard Chi-square test was used for categorical variables, whereas ANOVA tests were used for continuous variables. Standard t-tests were used to analyze clinical outcomes separately for each patient group. Since differences in baseline parameters between the four groups were found, multivariate linear and logistic regressions were used to further analyze the association between lower extremity pain and clinical outcomes. The variables in the linear and logistic regressions were age, sex, Body Mass Index, smoking status, preoperative ODI, preoperative NRS-score for leg pain and preoperative NRS-score for low back pain. Age, Body Mass Index, preoperative ODI and EQ-5D were included as linear variables and smoking status, sex and the NRS-scores were categorical variables. When analyzing the probability to be classified as successfully treated logistic regression were used, adjusting for baseline values.There were 3181 patients with lumbar spinal stenosis who underwent decompressive surgery in this register cohort. None of these patients had spinal co diagnosis. Regarding preoperative pain in the lower extremities, there were 154 patients in group 1; 753 patients in group 2; 1766 patients in group 3; and 528 patients in group 4 .The follow up response rate after 12 months was around 80% (77.8–81.0%) , but not between group 2 and group 1 (p = 0.23).The percentage of patients classified as being successfully treated (30% better ODI than preoperatively) in each of the four groups is presented in Fig. The mean changes from baseline to 12 months follow up are given in Table In this cohort we studied patients with lumbar spinal stenosis undergoing decompression surgery, as reported to the Norwegian Registry for Spine Surgery (NORspine). Regarding the primary outcome (change in ODI), and secondary outcomes , we found a significantly lower improvement among patients with insignificant preoperative lower extremity pain, compared to the other groups with more severe leg pain. These findings are in accordance with the findings of Kleinstuck et al. , who repPatients with insignificant preoperative lower extremity pain reported a worsening in mean values for lower extremity pain after surgery.However, a majority of patients in the present study reported an improvement in outcome parameters, even those patients with insignificant preoperative lower extremity pain. The mean improvement was 8 ODI points in this group, and 55.6% reported a reduction of at least 30% in ODI score at12 months follow up Fig. a.Fig. 4NIt may be argued that patients without pain radiating to the lower extremities do not fulfil the clinical criteria for spinal stenosis and should not have had surgery. Whether the improvement is due to the surgery, or a placebo effect, or the postoperative rehabilitation program, is difficult to determine. It is documented within other orthopedic fields that also sham surgery has effect on clinical outcomes –29.The patients in group 1 had significantly lower pain- and function score at baseline compared to the other groups. They would require less improvement to achieve a 30% reduction of the ODI-score, compared to those high baseline score.. This may be part of the explanation for why the four groups show no significant difference in success rate in the unadjusted analysis. However, when adjusting for the differences in the baseline scores, the logistic regression analysis showed significant difference between the groups in the predicted number of patients reaching a 30% improvement of ODI score. The patients with less lower extremity pain have a statistically significant higher proportion of patients with inferior outcome compared to patients with higher degree of lower extremity pain.In the NASS-criteria for clinical symptoms it is stated that low back pain, gluteal pain and lower extremity pain are symptoms of lumbar spinal stenosis.Patients may find it difficult to fit their symptoms into a standardized questionnaire used in a registry, so there may be errors in preoperative classification. It might be difficult to identify the exact location of their symptoms . In the Two of the main symptoms of lumbar spinal stenosis, neurogenic claudication and relief of pain while bending forward, are not asked about, either in the patients’ or in the surgeons’ questionnaires. These are amongst factors that may influence the clinical outcome after surgery, which cannot be accounted for in the present register study. Some would claim that patients with insignificant lower extremity pain do not have the cardinal symptom of lumbar spinal stenosis, and therefore should not have undergone surgery. The results of the present study show that the clinical outcome in patients with insignificant lower extremity pain could be interpreted as inferior. Some of these factors may account for the possibly inferior clinical outcome accounted for in patients with insignificant lower extremity pain.Recently it has been questioned if the Oswestry Disability Index is well enough validated for patients with spinal stenosis  . HoweverThe success-rate, reported in the present study is based on success criterion of 30% reduction from baseline ODI. There were no differences in the proportion of patients registered as successfully treated in the four groups. This indicates that some patients have benefited from surgery. There is no consensus, to our knowledge, as to what are the best criteria for determining a successful result of surgery for this group of patients, and more research is needed to define optimal criteria for success .The NORspine register does not include objective radiological parameters. The patients and the surgeon can have misinterpreted the symptoms of lumbar spinal stenosis. The Wakayama study from Japan , showed This is an observational register-cohort study, and therefore reflects a variation of practice amongst the Norwegian surgeons performing spinal surgery. Information about multiple patient-related factors that influence the decision making of the surgeon is not always possible to incorporate in a registry. To answer specific questions, one needs to perform a prospective comparative trial, preferably a randomized trial.A register trial has a high external validity. This is a cohort from most of the hospitals performing spinal surgery in Norway in the given period. The high numbers of patients in the study strengthens the validity of the results.The surgical techniques used in this study are similar, and have been documented not to influence the clinical outcome. All patients in the present study had surgery for lumbar spinal stenosis with spinal decompression with a midline retaining method , without additional fusion. A previous study from the same register showed similar clinical results after using these three posterior decompression techniques .In this national register study the analysis show that patients with insignificant lower extremity pain had less improvement in primary and secondary outcome parameters from baseline to follow-up compared to patients with more severe lower extremity pain.


The opioid crisis is public health emergency, in part due to physician prescribing practices. As a result, there is an increased interest in reducing narcotic use in the postsurgical setting.From January 1, 2018, to October 31, 2018, we employed a multidisciplinary, multimodal Enhanced Recovery After Surgery (ERAS) pathway abdominally based free tissue transfer involving the rectus. Preoperative, intraoperative, and postoperative nonnarcotic modalities were emphasized. Factors in reducing narcotic consumption, pain scores, and antiemetic use were identified.Forty-two patients were included for a total of 66 free flaps, with a 98.4%(65/66) success rate. Average postoperative in-hospital milligram morphine equivalent (MME) use was 37.5, but decreased 85% from 80.9 MME per day to 12.9 MME per day during the study period. Average pain scores and antiemetic doses also decreased. Postoperative gabapentin was associated with a significant 59.8 mg decrease in postoperative MME use, 21% in self-reported pain, and a 2.5 fewer doses of antiemetics administered but increased time to ambulation by 0.89 days. Postoperative acetaminophen was associated with a significant 3.0 point decrease in self-reported pain.This study represents our early experience. A shift in the institutional mindset of pain control was necessary for adoption of the ERAS protocol. While the ERAS pathway functions to reduce stress and return patients to homeostasis following surgery, postoperative gabapentin resulted in the greatest reduction in postoperative opioid use, self-reported pain, and postoperative nausea vomiting compared to any other modality. Various core elements of ERAS care throughout the preadmission, preoperative, intraoperative, and postoperative process are critical to success.2 The ERAS pathway was initially used in the setting of colorectal surgery, but has been shown to improve outcomes in many other surgical specialties.7 In microsurgical breast reconstruction, the ERAS pathway reduces pain scores, opioid use, and length of stay, resulting in significant cost savings, without increasing complication rates compared with traditional postoperative care.12 Furthermore, ERAS strategies result in earlier mobilization, decreased nausea, and increased patient satisfaction.14Enhanced recovery after surgery (ERAS) was described by Denmark surgeon, Henrik Kehlet, in 1997.17 Spurred by the introduction of pain as a fifth vital sign and fueled by pharmaceutical companies, sales of oxycodone and methadone quadrupled between 1997 and 2002.18 Opioid-related deaths are at an all-time high with 115 Americans dying each day from overdoses in 2016; 40% of these deaths are the result of prescription opioids.15 The US Department of Health and Human Services has declared the opioid crisis a public health emergency making reevaluation of postsurgical prescribing practices critical at this juncture.17Such discussion is highly relevant in light of the opioid epidemic facing the United States.12 the contribution of each component within the ERAS pathway in decreasing narcotic usage remains to be deciphered.11 Most studies attribute the success of the protocol to the synergistic multimodal therapies bestowing homeostasis after surgical stress, without delineating the effects of each individual item.11 We present our experience in implementing our ERAS protocol in autologous breast reconstruction patients and the effect on opioid use, pain scores, and doses of antiemetic medications. Furthermore, we seek to examine the contribution of each modality within the ERAS protocol to reduce narcotic usage and postoperative nausea vomiting. Understanding the components critical in reducing postoperative opioid use will enhance the application of ERAS protocols.Although it has been well established that the benefits of ERAS protocols for microvascular breast reconstruction are manifold,Over the past year , our ERAS protocol was employed through coordination with surgical teams, anesthesia teams, and nursing staff. A retrospective chart review was performed for 47 patients with the new protocol in place who underwent either unilateral, or bilateral breast reconstruction with muscle sparing transverse rectus abdominis muscle (MS-TRAM) or deep inferior epigastric artery perforator (DIEP) flaps with IRB approval (MHRI #2018–173). Patients receiving only superficial inferior epigastric artery (SIEA) and the vertical upper gracilis flaps were eliminated from analysis. All operations were conducted by the same surgeon at a single institution. Demographic information was collected, and medications they received preoperatively, intraoperatively, postoperatively, and upon discharge from the hospital.10The current iteration of our ERAS protocol for microvascular breast reconstruction was developed by the multidisciplinary coordination between our anesthesia, surgical, and nursing teams Fig. . Preoper19 Patients were discharged with the same nonnarcotic analgesics as given in hospital along with 5–10 tablets of narcotic (oxycodone 5 mg) for severe pain.Postoperatively, a standardized recovery regimen was initiated with a clear understanding of surgical milestones between the patient, nursing staff, and surgical teams. Visually highlighting these milestones in the patient rooms have been helpful in encouraging participation. Patients were given around the clock intravenous ketorolac for 24 hours (unless contraindicated) followed by per oral (PO) celecoxib, PO acetaminophen, and/or PO gabapentin. Narcotics were provided only for breakthrough pain. Doppler checks were not employed. Instead, nursing staff checked tissue oximetry , and alerted surgical teams during acute drops.All data were compiled into Microsoft Excel. The data were organized by patient. Opioid medications were coded separately, and subsequently converted to milligram morphine equivalents (MMEs) to standardize opiate use across patients. The total amount of MME was divided by the length of stay to give the final outcome variable of average daily MME for each patient. Average pain throughout the hospital stay was averaged by nursing records of patients’ self-reported pain—given on an increasing 10-point scale. The number of antiemetic doses (4 mg ondansetron or 12.5 mg promethazine) given during the hospital stay was summed in total.t-test was used to compare differences between means. Linear regression was used to determine which ERAS medications correlated to the 4 major outcomes of interest: daily MME use, average pain, antiemetic use, and length of hospital stay. The 4 major outcomes of interest were converted into binary variables, and Fischer’s exact test was used to determine odds ratios from 2 × 2 contingency tables for the ERAS medications and all 4 of these variables. A 2-tailed value of P <0.05 was considered statistically significant, and 95% confidence intervals are reported. All statistical analyses were conducted using IBM SPSS Statistics for Macintosh, version 25.Student’s Forty-two patients were included in the analysis, with a total of 66 flaps . The 2 SIEA flaps included in the analysis had an MS-TRAM on one side. Five patients were eliminated from analysis due to having only SIEA flaps. Twenty-three patients had immediate reconstructions, and 19 were delayed reconstructions. All operations were conducted by the senior surgeon at a single institution. Of the operative complications, one patient undergoing bilateral MS-TRAM suffered a flap failure POD6 after discharge due to undiscovered hypercoagulability disorder before surgery (Factor V Leiden) for a 98.4% (65/66) flap success rate. Another unilateral DIEP was salvaged after a take back for venous insufficiency POD1 detected on tissue oximetry. One patient required intraoperative evacuation of a hematoma that developed underneath her flap POD3 while ambulating. Another patient required interventional radiology (IR) drainage of an abdominal wall seroma after drains were removed POD17. The incidence of breast delayed wound healing was 11%, abdominal delayed wound healing was 14%, seroma rate was 2%, hematoma rate was 3%, and incidence of cellulitis was 3%.P = 0.029) and the number of flaps (P = 0.031) performed were statistically significantly correlated with abdominal wound healing complications. Smoking was significantly associated with seroma (P = 0.000) and infection (P = 0.000). There was no association between administration of ERAS medications and surgical complications (P > 0.05). There were 2 visits to the emergency room after discharge, one for abdominal seroma drained by interventional radiology the following day, and one for pulmonary embolism despite home prophylactic enoxaparin. There were no emergency room visits for uncontrolled pain.BMI (P > 0.05).Forty-three percent of patients received all ERAS  medications preoperatively. Intraoperatively, liposomal bupivacaine was used in 83% of cases for a rectus sheath and incision block. Eighty-five percent of patients received either intravenous lidocaine or ketamine. Intravenous acetaminophen was administered in 95% of patients. Intravenous ketorolac was administered 21% of the time. Intraoperative narcotics were used in all cases, either fentanyl or hydromorphone. Average MME use per case was 134.8 mg. Eighty-three percent of patients received all ERAS medications postoperatively. Average MME use per day was 35.7 for this cohort, but decreased significantly throughout the study period , decreased average self-reported pain by 2.47 points , but increased the number days to ambulation by 0.837 days . Linear regression was also run using all ERAS medications as independent variables to determine which medications had the greatest effect on postoperative opioid use, average self-reported pain while in the hospital, antiemetic use while in the hospital, and average hospital stay ; a 2.1-point decrease  in average self-reported pain while in the hospital ; and a 2.5 dose decrease in the number of antiemetic doses given during hospital stay . However, gabapentin was associated with a 0.89-day increase in days to ambulation . Preoperative and postoperative acetaminophen use was also associated with a 2.9  and 3.0  point decrease, respectively, in average self-reported pain while in the hospital.Linear regression demonstrated use of all preoperative  and intraoperative  ERAS medications which did not result in significant change in examined measures Table . The useP = 0.0321, OR = 8.286, 1.255–54.707), and the odds of average self-reported pain below 5 by 16 times . The use of gabapentin in the postoperative period was not associated with the increased the odds of a patient requiring less than 5 antiemetic or length of stay (P > 0.05).To further analyze the effect of gabapentin, bivariate analysis was performed to calculate the odds of MME average less than 50 mg per day, less than 5 antiemetic doses, average self-reported pain less than 5, length of hospital stay ≤3 days, and ambulation by POD2 after postoperative gabapentin use were calculated , opioid usage (to 55.6 MME per day), and pain scores. Although our length of stay was similar (3.8 days), our narcotic usage was lower overall (35.7 MME per day), and dramatically lower in the last 5 patients because employment of our ERAS protocol (12.9 MME per day). Astanehe et al similarly found a 13 MME per day average narcotic requirement after full application of their ERAS protocol, with a 4.8 day length of stay in a cohort of 330 microvascular breast reconstructions.3The ERAS protocol has been shown to be beneficial in multiple forms of breast surgery, including prosthetic- and autologous-based reconstruction.9 However, the main narcotic reducing components of the pathway remain to be understood.11 Some applications are prohibitive due to clinical restrictions; for example, not all institutions have liposomal bupivacaine available.11 Therefore, distilling the key elements of the ERAS pathway is critical to understanding its significance. This is the first study to identify postoperative gabapentin as critical in significantly reducing average postoperative MME use per day by 59.8 mg, a 21% in pain scores, and a reduction of 2.5 doses of antiemetics during the hospital stay after microvascular breast reconstruction. Gabapentin significantly increased odds by 8.3 times that patients would receive less 50 mg MME per day, and 16 times increased odds of average pain scores below 5. Acetaminophen significantly reduced self-reported pain scores by an average of 3.0 points. These findings were similar to that of Barker et al,24 who demonstrated significantly decreased postanesthesia narcotic use with multiple preoperative ERAS medications  in outpatient breast surgery.Because of the reduction in narcotic use, decreased antiemetic requirement, decreased length of stay, and cost savings, several authors have called for ERAS to be the standard of postoperative care in microsurgical breast reconstruction.25 In large meta-analyses, gabapentin has been associated with significantly decreased narcotic usage and pain scores.27 At 24 hours, Mishriky et al26 found an 8.28 MME decrease, but an increase in sedation, dizziness, and visual disturbance at 24 hours. In a double randomized controlled trial, a single dose of 600 mg gabapentin administered before mastectomy was associated with significantly decreased pain scores and morphine consumption postoperatively, without significant differences in dizziness, nausea/vomiting, or blurred vision.30 Gabapentin was associated with an increase in days until ambulation on linear regression for our cohort. Studies have generally found postoperative gabapentin more efficacious than a single preoperative loading dose, as our results confirm.32Gabapentin works through mitigating neuropeptide release by binding voltage-sensitive calcium channels within cortical and dorsal horn neurons.13 Buy-in from nursing staff, anesthesia providers, residents, and other advanced practitioners were necessary in effecting these changes.10 Although the surgically directed components of our ERAS protocol were consistent and showed significant positive effect, future collaborative efforts need to be directed at reduction in intraoperative MME. Prior, liberal use of narcotic analgesia was fueled by emphasis of pain as a fifth vital sign, and concerns over Press–Ganey scores.18 However, when explained, patients anticipate nonnarcotic pain control and make mental preparations for surgical milestones, such as out of bed to chair, ambulating, and going home. With education by the surgical team, perioperative narcotic usage decreased over time. Upon discharge, we observed no return to the emergency room for additional pain medication. Anecdotally, patients did not request them in office either.Because ERAS protocol implementation, we have observed a dramatic and sustained decrease in narcotic usage, pain scores, and antiemetic use. Detailed preoperative and postoperative counseling of the postoperative recovery course was critical in shifting the culture of pain control and decreasing narcotic usage.33 In their examination of ERAS protocol in microvascular breast reconstruction, a plan involving nursing staff was critical in reducing overall pain scores, and length of stay from 6.2 days to 72 hours. Additionally, eliminating disruptive Q1 hour doppler checks and relying on tissue oximetry has been instrumental in helping patients get rest. Placing patients on a surgical floor, instead of a loud intensive care unit has also helped in that regard. Although the ERAS protocol did not significantly change length of stay in our cohort, our length of stay was low at 3.8 days.9Although microvascular breast reconstruction has been historically viewed as a major operation at our center, enacting this protocol has shifted the institutional mindset, similar to that described by Bonde et al.9 evolved their TAP block technique from open exposure of the plane, injection by ultrasound guidance, to now with injection based on tactile feedback and a blunted needle. In that study, liposomal bupivacaine, postoperative ketorolac, shorter length of surgery, and goal-directed fluid management resulted in decrease in opioid use and length of stay. Gabapentin was not used in this cohort.9 It is possible a properly performed TAP block with the addition of gabapentin have synergistic effects in reducing narcotic consumption. Similarly, paravertebral blocks have been demonstrated to be effective in breast reconstruction in reducing postoperative pain and length of stay, without comprising blood pressure or intraoperative fluid requirements.36 Dexamethasone was used for postoperative nausea and vomiting prophylaxis in this study.37 However, dexamethasone can improve pain control as well, and wider use may be warranted perioperatively in nondiabetic patients.37In this cohort, transversus abdominis plane (TAP) blocks were not performed. Instead, we perform rectus sheath blocks with liposomal bupivacaine, which on regression was found not to be significant in reducing MME usage, pain scores, number of doses of antiemetics, time to ambulation, or length of stay. Afonso et al11 has had success giving clear fluids immediately after surgery. In the absence of surgical complications, Batdorf et al10 provides patients with a solid diet on POD 0. Although intravenous lidocaine was used intraoperatively in the majority of our patients, no direct benefit was observed on regression. The majority of trials and meta-analysis demonstrating reduced pain with intraoperative intravenous lidocaine were performed in open or laparoscopic abdominal procedures.38 In double blind trials in mastectomy patients, intravenous lidocaine did not affect opioid consumption, postoperative nausea vomiting, or pain scores,39 although there is some evidence it is protective against chronic postsurgical pain.40Although we employ an nil per Os (NPO) period until early POD1, Astanehe et al44Ultimately, the retrospective, single institution nature of this examination limits the applicability of its conclusions. The application of the ERAS protocol was heterogenous in nature due to the initial learning curve and patient contraindications. Furthermore, we did not critically examine prescribing practices on follow-up. Although cost analysis was not performed, several studies have highlighted direct cost savings of ERAS protocol and liposomal bupivacaine by reducing hospital stay, cost of drugs, and unscheduled outpatient visits.Full implementation of our ERAS protocol required a cultural shift in the way providers, staff, and patients viewed pain control. When applied, the ERAS protocol dramatically reduced postoperative narcotic consumption, pain scores, and antiemetic usage in our microvascular breast reconstruction patients. Although all components of the ERAS pathway function to reduce stress after surgery and achieve homeostasis, postoperative gabapentin use in our series resulted in the greatest reduction in postoperative opioid use, self-reported pain, and postoperative nausea vomiting than any other preoperative, intraoperative, or postoperative modality.