Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection. Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Laparoscopic exploration of common bile duct with primary closure versus T-tube drainage: a randomized clinical trial. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Radiofrequency fistulotomy: a better alternative for treating low anal fistula. Incisional hernia after upper abdominal surgery: a randomised controlled trial of midline versus transverse incision. Impact of presentation of research results on likelihood of prescribing medications to patients with left ventricular dysfunction. Laparoscopic versus open appendectomy: a prospective randomized double-blind study. Balloon angioplasty versus bypass grafting in the era of coronary stenting. Hospital-based comprehensive cardiac rehabilitation versus usual care among patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease: 12-month results of a randomized clinical trial.
Routine laxatives may expedite gastrointestinal recovery and early tolerance of food within an enhanced recovery after surgery (ERAS) programme. Combined with carbohydrate loading and oral nutritional supplements (ONS), it may further enhance recovery of gastrointestinal function and promote earlier overall recovery.
                Seventy-four patients undergoing liver resection were randomized in a two-by-two factorial design to receive either postoperative magnesium hydroxide as a laxative, preoperative carbohydrate loading and postoperative ONS, their combination or a control group. Patients were managed within an ERAS programme of care. The primary outcome measure was time to first passage of stool. Secondary outcome measures were gastric emptying, postoperative oral calorie intake, time to functional recovery and length of hospital stay.
                Sixty-eight patients completed the trial. The laxative group had a significantly reduced time to passage of stool: median (interquartile range) 4 (3-5) versus 5 (4-6) days (P = 0.034). The ONS group showed a trend towards a shorter time to passage of stool (P = 0.076) but there was no evidence of interaction in patients randomized to the combination regimen. Median length of hospital stay was 6 (4-7) days. There were no differences in secondary outcomes between groups.
                Within an ERAS protocol for patients undergoing liver resection, routine postoperative laxatives result in an earlier first passage of stool but the overall rate of recovery is unaltered.
                Copyright (c) 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. In an era of dwindling hospital resources and increasing medical costs, safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare resources. Although several protocols have been reported to reduce postoperative stay, no Level I evidence exists for their use in routine clinical practice.
                Sixty-four patients undergoing laparotomy and intestinal or rectal resection were randomly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care. Time to discharge from hospital, complication and readmission rates, pain level, quality of life, and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery. Subgroups were defined to evaluate those who derived the optimal benefit from the protocol.
                Pathway patients spent less total time in the hospital after surgery (5.4 vs. 7.1 days; P = 0.02) and less time in the hospital during the primary admission than traditional patients. Patients younger than 70 years old had greater benefits than the overall study group (5 vs. 7.1 days; P = 0.01). Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway (P = 0.01). There was no difference between pathway and traditional patients for readmission or complication rates, pain score, quality of life after surgery, or overall satisfaction with the hospital stay.
                Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet. Pathway patients have a shorter hospital stay, with no adverse effect on patient satisfaction, pain scores, or complication rates. Patients younger than 70 years of age derive the optimal benefit, and increased surgeon experience improves outcome. Several studies have shown that goal-directed hemodynamic and fluid optimization may result in improved outcome. However, the methods used were either invasive or had other limitations. The aim of this study was to perform intraoperative goal-directed therapy with a minimally invasive, easy to use device (FloTrac/Vigileo), and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a standard management protocol.
                In this randomized, controlled trial 60 high-risk patients scheduled for major abdominal surgery were included. Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol (FloTrac/Vigileo device, GDT-group, n = 30) or a standard management group (Control-group, n = 30), based on standard monitoring data.
                The median duration of hospital stay was significantly reduced in the GDT-group with 15 (12 - 17.75) days versus 19 (14 - 23.5) days (P = 0.006) and fewer patients developed complications than in the Control-group [6 patients (20%) versus 15 patients (50%), P = 0.03]. The total number of complications was reduced in the GDT-group (17 versus 49 complications, P = 0.001).
                In high-risk patients undergoing major abdominal surgery, implementation of an intraoperative goal-directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a standard management protocol.
                Clinical trial registration information: Unique identifier: NCT00549419. Traditionally, the common bile duct (CBD) is closed with T-tube drainage after choledochotomy and removal of CBD stones. However, the insertion of a T-tube is not without complication and the patients have to carry it for several weeks before removal. In the laparoscopic era, surgery is performed with minimally invasive techniques in order to reduce the trauma, hasten recovery, and reduce the hospital stay of patients. T-tube insertion seems to negate these benefits. This randomized study was designed to compare the two methods applied after LCBDE and to determine whether primary closure can be as safe as closure with T-tube drainage.
                From May 2000 to January 2008, 93 consecutive patients with common bile duct stones (CBDS) and gallbladder in situ were enrolled in this randomized study to undergo laparoscopic cholecystectomy with laparoscopic common bile duct exploration (LCBDE). Intraoperative findings, postoperative complications, postoperative stay, and hospital expenses were recorded and analyzed.
                There was no mortality in both groups. A T-tube was inserted in 46 patients and the CBD was closed primarily in 47. There were no differences in the demographic characteristics or clinical presentations between the two groups. Compared with the T-tube group, the operative time and postoperative stay were significantly shorter, the hospital expenses were significantly lower, and the incidences of overall postoperative complications and biliary complications were statistically and insignificantly lower in the primary closure group.
                LCBDE with primary closure without external drainage after laparoscopic choledochotomy is feasible and as safe as T-tube insertion. A fast-track program is a multimodal approach for patients undergoing colonic surgery that combines stringent regimens of perioperative care (fluid restriction, optimized analgesia, forced mobilization, and early oral feeding) to reduce perioperative morbidity, hospital stay, and cost. We investigated the impact of a fast-track protocol on postoperative morbidity in patients after open colonic surgery.
                A randomized trial of patients in 4 teaching hospitals in Switzerland included 156 patients undergoing elective open colonic surgery who were assigned to either a fast-track program or standard care. The primary end point was the 30-day complication rate. Secondary end points were severity of complications, hospital stay, and compliance with the fast-track protocol.
                The fast-track protocol significantly decreased the number of complications (16 of 76 in the fast-track group vs 37 of 75 in the standard care group; P = .0014), resulting in shorter hospital stays (median, 5 days; range, 2-30 vs 9 days, respectively; range, 6-30; P < .0001). There was a trend toward less severe complications in the fast-track group. A multiple logistic regression analysis revealed fluid administration greater than the restriction limits (odds ratio, 4.198; 95% confidence interval, 1.7-10.366; P = .002) and a nonfunctioning epidural analgesia (odds ratio, 3.365; 95% confidence interval, 1.367-8.283; P = .008) as independent predictors of postoperative complications.
                The fast-track program reduces the rate of postoperative complications and length of hospital stay and should be considered as standard care. Fluid restriction and an effective epidural analgesia are the key factors that determine outcome of the fast-track program. Wide varieties of approaches are employed in dealing with low anal fistula. However, the simple method of laying open the fistula tract (fistulotomy) is still considered to be the favored one.
                A modified approach to the procedure of fistulotomy is discussed. This study describes the procedure, which used a technique of radiofrequency surgery, and its outcome in 232 patients with low anal fistula. The patients were followed for a period of 15 months.
                The patients were discharged on the same day as the procedure. The mean period off work was four days. The average healing time recorded was 67 days. Four wound complications in the form of premature closure of the external wound were noted, which required trimming of the edges. Two of these wounds remained unhealed. The recurrence rate was 1.7%.
                In this era when the emphasis is on criteria like the minimization of hospital stay, reduction of postoperative pain, early resumption of work and low and comparable recurrence rates, there is a future for the procedure of radiofrequency fistulotomy. To determine whether a transverse incision is an alternative to a midline incision in terms of incisional hernia incidence, surgical site infection, postoperative pain, hospital stay and cosmetics in cholecystectomy. Incisional hernias after midline incision are commonly underestimated but probably complicate between 2 and 20% of all abdominal wall closures. The midline incision is the preferred incision for surgery of the upper abdomen despite evidence that alternatives, such as the lateral paramedian and transverse incision, exist and might reduce the rate of incisional hernia. A RCT was preformed in the pre-laparoscopic cholecystectomy era the data of which were never published.
                One hundred and fifty female patients were randomly allocated to cholecystectomy through midline or transverse incision. Early complications, the duration to discharge and the in-hospital use of analgesics was noted. Patients returned to the surgical outpatient clinic for evaluation of the cosmetic results of the scar and to evaluate possible complications such as fistula, wound dehiscence and incisional hernia after a minimum of 12 months follow-up.
                Two percent (1/60) of patients that had undergone the procedure through a transverse incision presented with an incisional hernia as opposed to 14% (9/63) of patients from the midline incision group (P = 0.017). Transverse incisions were found to be significantly shorter than midline incisions and associated with more pleasing appearance. More patients having undergone a midline incision, reported pain on day one, two and three postoperatively than patients from the transverse group. The use of analgesics did not differ between the two groups.
                In light of our results a transverse incision should, if possible, be considered as the preferred incision in acute and elective surgery of the upper abdomen when laparoscopic surgery is not an option. This study was conducted to evaluate willingness to prescribe medication based on identical data presented in different outcome terms to health professionals of varied discipline, geographic location, and level of training. Cross-sectional survey using a self-administered questionnaire was performed in 400 health professionals (physicians, pharmacists, physicians-in-training, and pharmacy students) in the United States and Europe. Data reflecting a clinical trial were presented in 6 outcome terms: 3 terms describing identical mortality (relative risk reduction, absolute risk reduction, and number of patients needed to be treated to prevent 1 death); and 3 distractors (increased life expectancy, decreased hospitalization rate, and decreased cost). Willingness to prescribe and rank order of medication preference assuming willingness to prescribe were measured. The results of the study showed that willingness to prescribe and first choice preference were significantly greater when study results were presented as relative risk reduction than when identical mortality data were presented as absolute risk reduction or number of patients needed to be treated to avoid 1 death (p <0.001). Increase in life expectancy was the most influential distractor. In conclusion, this study, performed in the era of "evidence-based medicine," demonstrates that the method of reporting research trial results has significant influence on health professionals' willingness to prescribe. The high numerical value of relative risk reduction and the concrete and tangible quality of increased life expectancy exert greater influence on health professionals than other standard outcome terms. The value of laparoscopy in appendicitis is not established. Studies suffer from multiple limitations. Our aim is to compare the safety and benefits of laparoscopic versus open appendectomy in a prospective randomized double blind study.
                Two hundred forty-seven patients were analyzed following either laparoscopic or open appendectomy. A standardized wound dressing was applied blinding both patients and independent data collectors. Surgical technique was standardized among 4 surgeons. The main outcome measures were postoperative complications. Secondary outcome measures included evaluation of pain and activity scores at base line preoperatively and on every postoperative day, as well as resumption of diet and length of stay. Activity scores and quality of life were assessed on short-term follow-up.
                There was no mortality. The overall complication rate was similar in both groups (18.5% versus 17% in the laparoscopic and open groups respectively), but some early complications in the laparoscopic group required a reoperation. Operating time was significantly longer in the laparoscopic group (80 minutes versus 60 minutes; P = 0.000) while there was no difference in the pain scores and medications, resumption of diet, length of stay, or activity scores. At 2 weeks, there was no difference in the activity or pain scores, but physical health and general scores on the short-form 36 (SF36) quality of life assessment forms were significantly better in the laparoscopic group. Appendectomy for acute or complicated (perforated and gangrenous) appendicitis had similar complication rates, regardless of the technique (P = 0.181).
                Unlike other minimally invasive procedures, laparoscopic appendectomy did not offer a significant advantage over open appendectomy in all studied parameters except quality of life scores at 2 weeks. It also took longer to perform. The choice of the procedure should be based on surgeon or patient preference. Patients with multivessel coronary artery disease are candidates for either angioplasty and stenting or coronary artery bypass grafting. A prospective randomized study designed to compare the both methods included only a minority of the eligible patients.
                To compare coronary artery bypass grafting to angioplasty plus stenting in patients with multivessel disease who declined randomization to a multicenter study (the ARTS).
                During 1997-98 we prospectively followed 96 consecutive patients who were eligible according to the ARTS criteria but refused randomization. Of these patients, 50 underwent angioplasty + stenting and 46 underwent coronary bypass surgery. We compared the incidence of major adverse cardiac and cerebral events, chest pain recurrence, quality of life and procedural cost during the first 6 months.
                All procedures were completed successfully without mortality or cerebral events. The rate of Q-wave myocardial infarction was 2% in the AS group vs. 0% in the CABG group (not significant). Minor complications occurred in 7 patients (14%) in the AS group and in 21 patients (45%) in the CABG group (P < 0.01). At 6 months follow-up the incidence of major cardiac and cerebral events was similar in both groups (11% and 4% in the AS and CABG groups respectively, P = NS). Seventeen patients (36%) in the AS group required repeat revascularization compared to only 3 (7%) in the CABG group (P = 0.002). Nevertheless, quality of life was better, hospitalization was shorter and the cost was lower during the first 6 months after angioplasty.
                Angioplasty with stenting compared to coronary bypass surgery in patients with multivessel disease resulted in similar short-term major complications. However, 36% of patients undergoing angioplasty may need further revascularization procedures during the first 6 months. Current guidelines broadly recommend comprehensive cardiac rehabilitation (CCR), although evidence for this is still limited. We investigated the 12-month effect of hospital-based CCR versus usual care (UC) for a broadly defined group of cardiac patients within the modern therapeutic era of cardiology.
                We conducted a centrally randomized single-center clinical trial with blinded assessment of the primary outcome: registry-based composite of total mortality, myocardial infarction, or acute first-time readmission due to heart disease. Other outcomes were hospitalization, risk profile, and quality of life. The trial included 770 participants (20-94 years) with congestive heart failure (12%), ischemic heart disease (58%), or high risk of ischemic heart disease (30%). Comprehensive cardiac rehabilitation is composed of 6 weeks of intensive intervention and systematic follow-up for 10.5 months.
                We randomized 380 patients to CCR versus 390 to UC. Randomization was well balanced. The primary outcome occurred in 31% of both groups (relative risk 0.96, 95% confidence interval 0.78-1.26). Compared with the UC group, CCR significantly reduced length of stay by 15% (95% confidence interval 1.1%-27.1%, P = .04), mean number of cardiac risk factors above target (4.5 vs 4.1, P = .01), patients with systolic blood pressure below target (P = .003), physically inactivity (P = .01), and unhealthy dietary habits (P = .0003). Short-Form-36 and Hospital Anxiety and Depression Scale did not differ significantly.
                At 12 months, the CCR and UC groups did not differ regarding the primary composite outcome. Comprehensive cardiac rehabilitation significantly reduced length of hospital stay and improved cardiac risk factors.
The quantity and especially quality of data are low. Analysis shows a reduction in overall complications, but major complications were not reduced. Length of stay was reduced significantly. We state that ERAS seems safe, but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the standard of care. Within ERAS protocols included, no answer regarding the role for minimally invasive surgery (i.e. laparoscopy) was found. Furthermore, protocol compliance within ERAS programs has not been investigated, while this seems a known problem in the field. Therefore, more specific and large RCT's are needed.