Randomized study of non-closure of peritoneum in lower segment cesarean section. A randomized controlled study of peritoneal closure at cesarean section. Effectiveness of prolonged use of continuous passive motion (CPM), as an adjunct to physiotherapy, after total knee arthroplasty. Closure vs non-closure of the visceral and parietal peritoneum at cesarean delivery: 16 year study. Role of ect phenothiazine combination in schizophrenia. Long-term appearance of lacerations repaired using a tissue adhesive. Curative radiotherapy in non-small cell carcinoma of the lung. Anterior cervical discectomy (ACD) versus anterior cervical fusion (ACF), clinical and radiological outcome study. Butylcyanoacrylate tissue adhesive for columellar incision closure. Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others. Hemorrhoidal stapler prolapsectomy vs. Milligan-Morgan hemorrhoidectomy: a long-term randomized trial.
The advantages of non-closure of the visceral and parietal peritoneum at lower segment cesarean section seems to be evident but in the reports published so far, the number of patients studied has been relatively small and the follow-up periods short. It is obviously of value to reconfirm such important observation in several institutions and therefore, in 1991, we decided to study non-closure of the peritoneum in lower segment cesarean section in a large series of patients with long-term follow-up of at least one year.
                A prospective randomized study of 361 patients undergoing lower segment cesarean section in a University Affiliated Hospital, Al-Ain, United Arab Emirates. The operative technique was randomized to include either non-closure of both visceral and parietal peritoneum (study group, n = 179) or closure of both layers (control group, n = 182). Patients were followed up according to a study protocol. The nursing staff and the obstetricians responsible for data collection were unaware as to which of the two groups the patients belonged to. Student-t test and Chi-square test were used for statistical analysis of the results, where appropriate, with a p < 0.05 considered probability level to reflect significant differences.
                Postoperative febrile morbidity and wound infection were significantly lower in the study group as compared to the control group (p < 0.001 and p < 0.05 respectively). The incidence of wound dehiscence, urinary tract infection and the time to opening of the bowels postoperatively were similar in the two groups. In the non-closure group, the average operating time was significantly shorter by 7.9 minutes (p < 0.01) and the hospital stay was one day less (p < 0.01). There were no patients with late postoperative complications or readmissions during 2-5 years of follow-up that could be attributed to complications associated with lower segment cesarean section.
                Non-closure of the visceral and parietal peritoneum at lower segment cesarean section is associated with fewer postoperative complications, is more cost effective and is simpler than the traditional operative technique of closing both peritoneal layers. To assess the benefits or problems that may be associated with peritoneal closure at cesarean section.
                A randomized-controlled study of women undergoing cesarean section in Sultan Qaboos University Hospital Maternity Unit. After the decision is taken for cesarean section, women were randomized to either repair of peritoneum using standard technique or non-repair of peritoneum. Duration of operation, maternal morbidity, blood loss assessed by post-operative hemoglobin change and requirement of transfusion, post operative infection, thromboembolic disease, and length of hospital stay were analyzed in 2 groups of patients. Sixty women were randomized into the study, 30 group A, had peritoneal closure and 30, group B, and had non-closure.
                The average duration of operation for group A was 61.9+/-12.734, and for group B was 53.56 +/-11.209 (p< 0.01 statistically significant). There was no statistically significant difference in the length of stay, estimated blood loss, the mean drop in hemoglobin, postoperative pyrexia, and wound infection rate between the 2 groups.
                Our study has confirmed the previous study findings, and has shown that there are no advantages in suturing of the peritoneum in terms of blood loss, blood transfusion, operation duration, postoperative pyrexia and wound infection. In fact non-suturing of the peritoneum was associated with shorter operation duration (p< 0.01 significant), and reduced cost. Adequate and intensive rehabilitation is an important requirement for successful total knee arthroplasty. Although research suggests that Continuous Passive Motion (CPM) should be implemented in the first rehabilitation phase after surgery, there is substantial debate about the duration of each session and the total period of CPM application. A Cochrane review on this topic concluded that short-term use of CPM leads to greater short-term range of motion. It also suggested, however, that future research should concentrate on the treatment period during which CPM should be administered.
                In a randomised controlled trial we investigated the effectiveness of prolonged CPM use in the home situation as an adjunct to standardised PT. Efficacy was assessed in terms of faster improvements in range of motion (RoM) and functional recovery, measured at the end of the active treatment period, 17 days after surgery. Sixty patients with knee osteoarthritis undergoing TKA and experiencing early postoperative flexion impairment were randomised over two treatment groups. The experimental group received CPM + PT for 17 consecutive days after surgery, whereas the usual care group received the same treatment during the in-hospital phase (i.e. about four days), followed by PT alone (usual care) in the first two weeks after hospital discharge. From 18 days to three months after surgery, both groups received standardised PT. The primary focus of rehabilitation was functional recovery (e.g. ambulation) and regaining RoM in the knee.
                Prolonged use of CPM slightly improved short-term RoM in patients with limited RoM at the time of discharge after total knee arthroplasty when added to a semi-standard PT programme. Assessment at 6 weeks and three months after surgery found no long-term effects of this intervention Neither did we detect functional benefits of the improved RoM at any of the outcome assessments.
                Although results indicate that prolonged CPM use might have a small short-term effect on RoM, routine use of prolonged CPM in patients with limited RoM at hospital discharge should be reconsidered, since neither long-term effects nor transfer to better functional performance was detected.
                ISRCTN85759656. To determine whether non-closure of visceral and parietal peritoneum at LSCS has advantages over peritoneal closure with regard to postoperative complication and adhesions.
                Prospective randomized controlled trial.
                Paholpolpayuhasena Hospital, Kanchanaburi province, Thailand
                Three hundred and sixty full-term pregnant women undergoing first cesarean section were divided into 3 groups (N = 120). Group A: non-closure of both visceral and parietal peritoneum. Group B. non-closure of only visceral peritoneum. Group C: closure of both visceral and parietal peritoneum. Postoperative complications were compared. Adhesions were evaluated in 65 patients returning for a second LSCS and compared for severity of adhesions. The three groups were compared using statistical analysis.
                There was no significant statistical difference between group A and C, group B and C for postoperative complications or number of adhesion formation. However, adhesions in the closure group were more severe.
                Closure of visceral and parietal peritoneum has no benefit over non-closure of visceral peritoneum and non-closure of both visceral and parietal peritoneum at LSCS. A prospective double blind study was conducted to evaluate the role of E.C.T. in schizophrenia. Before the start of the trial patients were kept on chlorpromazine in adequate dosage for 30 days. Those who showed fifty percent or more improvement during this period were excluded. All patients were given eight modified or simulated E.C.T.s. The patients were followed up for one month. E.C.T. did not show any added advantage over chlorpromazine either initially or during short term follow-up. Histoacryl Blue (HAB), a tissue adhesive, has been shown to decrease laceration repair time, cause less pain to the child, eliminate the need for suture removal, and result in a similar short-term cosmetic outcome compared with conventional suturing. Reports suggest that poor correlation can exist between the short-term and long-term cosmetic outcomes for lacerations repaired by conventional suturing. Therefore, this study compares the long-term cosmetic outcome of HAB to conventional suturing for laceration repair in children.
                Prospective, randomized clinical trial.
                Children presenting an urban pediatric emergency department for laceration repair between October 1994 and February 1995 were eligible. Patients less than 1 or more than 18 years old, those with lacerations more than 5 cm in length, or in areas of high tension or mobility were excluded.
                After routine wound management, including subcutaneous closure when deemed necessary, patients were randomized to receive skin sutures or HAB for cutaneous closure. Photographs taken at the 2-month and 1-year follow-up visits were evaluated for cosmetic appearance by two plastic surgeons blinded to the method of repair.
                Sixty-one children were enrolled: HAB (N = 30), suture (N = 31). Thirty HAB and 25 sutured patients were assessed at 2 months, while 17 HAB and 15 sutured patients were reevaluated at 1 year. Patients that followed-up at 2 months and 1 year were comparable to those with no follow-up in: treatment group (HAB vs suture), demographics, wound characteristics, and initial parental satisfaction. The two plastic surgeons graded the cosmetic appearance of the wounds repaired by HAB to be comparable to those repaired by conventional suturing at both the 2-month and 1-year follow-up.
                The use of HAB is an ideal alternative to conventional suturing for the cutaneous closure of low tension lacerations in children with a long-term cosmetic outcome comparable to conventional suturing. Recent reports suggest radiotherapy administered to the 5000-6000 cGy level can result in significant long-term survival in non-small cell carcinoma of the lung. This is particularly true for many cases that are technically operable but for medical or other reasons thoracotomy cannot be performed. Such patients drawn from Southern Appalachia where the principal industry is coal mining are the subject of this report. In this region coal miners pneumoconiosis (black lung) is common as well as other chronic respiratory disorders resulting in poor tolerance for surgery. Three hundred and eleven cases of non-small cell carcinoma were irradiated during the 4 years of 1980 through 1983. This group consisted of 77 patients with clinical Stage T1, T2, T3 all N0, M0 tumors, the majority of which were technically operable but upon whom no thoracotomy was performed because of medical reasons or patient refusal. All are available for 5-year study. Each of these patients was uniformly irradiated to 6000 cGy target dose in 30 fractions over 6 weeks using standard techniques. Absolute or crude survival in these 77 patients is as follows: 1 year, 57%; 2 year, 36%; 3 year, 21%; 4 year, 17%; and 5 year, 17%. Comparison with reported surgical series treated for cure show little difference in survival up to 2 years. Thereafter, the survival curves diverge with radiotherapy patients dying at a somewhat higher rate although by 4 years both survival curves slope similarly. A possible explanation for this difference is the advantage thoracotomy offers in early case selection allowing exclusion of advance cases from surgical reports whereas radiotherapy must include patients with occult local metastasis not identifiable on clinical grounds. This experience, among other reports include evidence that radiotherapy can result in long-term survival or cure with minimal morbidity in lung cancer patients in whom surgery carries excessive risk. This study was conducted on 90 patients with symptomatic cervical disc disease with one or two-level disc pathology. Clinical and radiological outcome was compared to determine which technique was advantageous for patients with disc disease. Problems related to donor site as well as those related to fusion bed and grafts have stimulated investigators to avoid fusion. Patients were allocated at random for either the ACF (n=50) or the ACD (n=40) procedures. The standard Smith-Robinson technique was performed on all patients in this study. Patients were followed-up clinically and radiologically according to the study protocol. The clinical long-term outcome was comparable in both groups, though those who had ACF were more satisfied. There was significant incidence of kyphosis in the ACD group (P=0.02). Osseous union was slow and less satisfactory with ACD (64%) than with ACF (94%). Pain at the donor site was not a significant problem in the long-term. Hospital stay and operative time was shortened in ACD patients though not significantly. Spondylotic patients were less satisfied with ACD though not significantly. Conclusions. The issue of whether to fuse or not to fuse has not come to an end yet. The technique is still in need of more refinement of disc excision and graft harvesting and shaping, as well as more adequately controlled studies. Until that, ACD has to be limited to those patients with a soft single disc without spondylosis. Cosmetic outcome of the columellar incision closure in external rhinoplasty patients has been a subject of discussion. This study was conducted to assess whether tissue adhesives provide an alternative option for sutureless closure of columellar skin incisions for cases utilizing open technique rhinoplastic surgery. One hundred and one patients undergoing external rhinoplasty were randomized to either topical application of butylcyanoacrylate or polypropylene sutures for columellar skin closure. The majority of tension on the wound edges was taken up using 5-0 chromic catgut. Cosmetic outcomes were evaluated by two otolaryngologists independently using visual analogue and Hollander wound evaluation scales in a blinded manner. There was no statistically significant difference in cosmesis between the surgeons' evaluation scores for either type or repair of the columellar incision. Since the tissue adhesive forms its own protective barrier, post-operative care is simplified. Closure with adhesives eliminates the need for post-operative suture removal requiring an extra visit that should lead to more efficient use of physician and patient time. Butylcyanoacrylate performs cosmetically as well as standard suture closure of columellar skin incision used for external rhinoplasty. Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.
                The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.
                299 study protocols were included. The most frequent study design was randomised controlled trial (141; 47%), followed by uncontrolled studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies (29; 10%). 182 (61%) were multicentre studies including 97 (53%) international collaborations. 152 of 299 (51%) had commercial (co-)funding and 46 (15%) non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication (total 210 articles); the publication rate was 48%. 168 of 210 identified publications (80%) were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication (range 0-1151).
                Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. The notable success of stapled prolapsectomy in recent years led us to compare this technique with Milligan-Morgan hemorrhoidectomy in terms of the results obtained both in the immediate postoperative period and in the long term.
                We performed conventional hemorrhoidectomy on 50 randomly selected patients and operated on a further 50 using the stapler technique. The patients were monitored over the immediate postoperative period (e.g., type of anesthesia, mean duration of operation, mean hospitalization time, analgesic administration, time before returning to work) and over a long-term follow-up period of 48 months (later complications such as prolapse relapse, bleeding, stenosis, incontinence).
                The stapled group experienced significantly less pain (mean number of analgesic tablets 2.60 vs. 15.9) and returned to normal activity sooner (8.04 vs. 16.9 days), as reported by other authors. In the long-term follow-up at 48 months, stapled hemorrhoidectomy was found to control prolapse, discharge, and bleeding, with no stenosis or significant incontinence, in 94% of cases.
                Our conclusions confirm the excellent advantages of stapled hemorrhoidectomy which allows the rapid recovery of patients and also promises the complete resolution of hemorrhoidal prolapse in the long term.
There is no evidence for any short-term or long-term advantage in peritoneal closure for non-obstetric operations. If further trials are performed on this topic, they should have an adequate period of follow-up and adequate measures should be taken to ensure that the results are not subject to bias.