Randomized clinical trial of laparoscopic versus open abdominal rectopexy for rectal prolapse. Comparison of laparoscopic rectopexy with open technique in the treatment of complete rectal prolapse: clinical and functional results. Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy. Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Laparoscopic Burch colposuspension: a randomized controlled trial comparing two transperitoneal surgical techniques. Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Comparison of polyglycolic acid and polypropylene mesh for rectopexy in the treatment of rectal prolapse. Anterior colporrhaphy: a randomized trial of three surgical techniques. Hand-assisted laparoscopic versus open restorative proctocolectomy with ileal pouch anal anastomosis: a randomized trial.
The objectives of this study were to compare both subjective clinical outcomes and the objective stress response of laparoscopic and open abdominal rectopexy in patients with full-thickness rectal prolapse. Abdominal rectopexy for patients with rectal prolapse is well suited for a laparoscopic approach as no resection or anastomosis is necessary.
                Forty patients with a full-thickness rectal prolapse were randomized before operation to a laparoscopic group and an open group. They agreed to conform to a clinical pathway (CP) of liquid diet (CP1) and full mobility (CP2) on day 1, solid diet (CP3) on day 2 and discharge (CP4) before day 5. Their compliance was monitored by an assessor blinded to the operative group, who also rated pain and mobility. Patient-controlled morphine use was documented. Neuroendocrine and immune stress response and respiratory function were measured.
                Some 75 per cent of all clinical pathway objectives of early recovery were achieved in the laparoscopic group compared with 37 per cent in the open group (P < 0.01). Significant differences in favour of laparoscopy were noted with regard to narcotic requirements, and pain and mobility scores. Differences in objective measures of stress response favouring laparoscopy were found for urinary catecholamines, interleukin 6, serum cortisol and C-reactive protein. No differences were noted in respiratory function but significant respiratory morbidity was greater in the open group (P < 0.05). None of the measured outcomes, subjective or objective, favoured the open group apart from operating time, which was significantly shorter (153 versus 102 min; P < 0.01).
                This study has demonstrated significant subjective and objective differences in favour of a laparoscopic technique for abdominal rectopexy. The advantages were all short term but no evidence of any adverse effect on longer-term outcomes was observed. The aim of this retrospective study was to compare the functional and clinical results of laparoscopic rectopexy with those of the open technique in two similar groups of patients with complete rectal prolapse and fecal incontinence. Between November 1992 and June 1997, 21 patients underwent abdominal rectopexy. Thirteen patients (group A: 12 women and 1 man, mean age 52.9 years, range 28-70) and 8 patients (group B: 8 women, mean age 58.2 years, range 20-76) were submitted to Well's rectopexy by the open technique and the laparoscopic approach, respectively, without division of the lateral rectal ligaments. Assignment to each group was done randomly. Before the operation, a detailed clinical history was taken, and patients were studied with inspection and digital examination of the anorectum, proctosigmoidoscopy, determination of pancolonic transit time, dynamic defecography, anorectal manometry, and anal electromyography. After the operation, all patients underwent perineal physiotherapy, external electric stimulation, and perineal biofeedback. The mean follow-up time was 29.5 months (range 6-54) in group A and 25.7 months (range 8-45) in group B. Values were compared by chi-square, Mann-Whitney U, and Wilcoxon tests, as appropriate; differences were considered significant at p < 0.05. In both groups, dyschezia and fecal incontinence improved significantly (p < 0.05) after the operation. Basal pressure of anal sphincter, squeezing pressure, and rectoanal reflex improved without significance, whereas anoperineal pain was not significantly reduced. In group B, the postoperative hospital stay was shorter than in group A, with a marked reduction of costs. Laparoscopic Well's rectopexy has the same clinical and functional results as the open technique, with a shorter postoperative hospital stay and lower costs. This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse.
                Subjects were randomly assigned to SIS (n = 29) or to TC (n = 27) preoperatively and outcomes analyzed at 12 months postoperatively. The primary outcome was the absence of POP-Q stage >or= II prolapse, and secondary outcome was improvement in quality of life. Data were compared with independent samples or paired Student's t test.
                SIS group had 86.2% anatomic cure compared to 59.3% in TC (p = 0.03). SIS improved point Ba measurement significantly (-1.93 cm versus -1.37 cm, p = 0.02). Both operations significantly improved quality of life, although there were no differences between the groups. We observed a greater number of complications in the SIS group, with no infections or erosion.
                SIS repair improved point Ba significantly. However, there were no differences observed in quality of life between the techniques. This assessor-blinded randomized controlled trial investigated the effect of a pre- and post-operative physiotherapy-supervised pelvic floor muscle (PFM) training program in women undergoing surgery for prolapse or hysterectomy.
                Participants were assessed pre-operatively, and at 3, 6, and 12 months post-operatively by a blinded physiotherapy assessor. Following randomization, participants were allocated to a control group (CG) which included "usual care" (as provided by the surgeon and the hospital staff), or a treatment group (TG) which included one pre-operative and seven post-operative treatment sessions over 12 months. Primary outcomes were bladder and prolapse symptoms, measured by the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ).
                Fifty-one participants were randomized. The 12-month post-operative findings showed there was no difference in the prevalence of the primary outcomes (ORs 1.2, 1.3). There were no significant differences between groups on the change scores of the UDI (mean: 44.1 [5.1]; 54.0 [5.4], P = 0.20) nor the IIQ (median: 0.0 [9,14]; 10.0 [5,19], P = 0.09). The repeated measures analyses also demonstrated no significant changes.
                The program tested did not improve bladder or prolapse symptoms in this trial. Reasons may include the effectiveness of surgery alone, wide variance in data, small sample size, insufficient training by the TG, and PFM training by the usual care group.
                (c) 2010 Wiley-Liss, Inc. To compare the effectiveness of two transperitoneal laparoscopic Burch procedures.
                The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an alpha = 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies.
                The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P <.05).
                Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique. 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. To compare the efficacy of absorbable and non-absorbable mesh for rectal fixation in abdominal rectopexy.
                Prospective open study.
                University hospital, Israel.
                37 consecutive patients with complete rectal prolapse.
                Posterior abdominal rectopexy with non-absorbable mesh (Polypropylene, Prolene, Ethicon Ltd) in 17 patients and with absorbable mesh (Polyglycolic acid, Dexon, Davis & Geck) in 20.
                There was no operative mortality, and there were no significant differences between the groups in the incidence of postoperative complications. Mean (SD) follow up was 3.6(0.5) years and 3.8(0.7) years in the Dexon and Prolene groups, respectively. Preoperative and postoperative performance indices based on the Gastrointestinal Quality of Life Index were similar in both groups.
                Dexon mesh may be as effective as Prolene mesh in the treatment of complete rectal prolapse. A performance index seems to be a useful tool for evaluating the outcome of patients after repair of complete rectal prolapse. The purpose of this study was to compare outcomes after anterior colporrhaphy with the use of 3 different surgical techniques.
                One hundred fourteen women with anterior vaginal prolapse were randomly assigned to undergo anterior repair by one of 3 techniques: standard, standard plus polyglactin 910 mesh, or ultralateral anterior colporrhaphy. Before and after operation, patients underwent physical examination staging of prolapse; the International Continence Society system was used. Symptoms were assessed by questionnaire and visual analog scales. We defined "cure" as satisfactory (stage I) or optimal (stage 0) outcome at points Aa and Ba.
                Of 114 patients who were originally enrolled, 109 patients underwent operation, and 83 patients (76%) returned for follow-up. Mean age (+/- SD) was 64.7 +/- 11.1 years. At entry, 7 patients (7%) had stage I anterior vaginal prolapse; 35 patients (37%) had stage II anterior vaginal prolapse; 51 patients (54%) had stage III anterior vaginal prolapse; and 2 patients (2%) had stage IV anterior vaginal prolapse. At a median length of follow-up of 23.3 months, 10 of 33 patients (30%) who were randomly assigned to the standard anterior colporrhaphy group experienced satisfactory or optimal anatomic results, compared with 11 of 26 patients (42%) with standard plus mesh and with 11 of 24 patients (46%) with ultralateral anterior colporrhaphy. The severity of symptoms that were related to prolapse improved markedly (preoperative score, 6.9 +/- 2.7; postoperative score, 1.1 +/- 0.8). Twenty-three of 24 patients (96%) no longer required manual pressure to void after operation.
                These 3 techniques of anterior colporrhaphy provided similar anatomic cure rates and symptom resolution for anterior vaginal prolapse repair. The addition of polyglactin 910 mesh did not improve the cure rate compared with standard anterior colporrhaphy. The aim of the study was to evaluate postoperative recovery after hand-assisted laparoscopic or open restorative proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis and familial adenomatous polyposis in a randomized controlled trial.
                Sixty patients were randomized for hand-assisted laparoscopic (n = 30) or open surgery (n = 30). Primary outcome parameter was postoperative recovery in the 3 months after surgery, measured by quality of life questionnaires (SF-36 and GIQLI). Secondary parameters were postoperative morphine requirement and surgical parameters, viz. operating time, morbidity, hospital stay, and costs.
                There was no difference between the 2 procedures in quality of life assessment in the 3 months after surgery. There was a significant decline in quality of life on all scales of the SF-36 (P < 0.001) and total GIQLI score (P < 0.001) in the first 2 weeks in both groups (no significant difference between the groups). Quality of life returned to baseline levels after 4 weeks. Operating times were longer in the laparoscopic group compared with the open group (210 and 133 minutes, respectively; P < 0.001). No significant differences were found in morphine requirement. Neither morbidity nor postoperative hospital stay differed between the laparoscopic and open group (20% versus 17%, in 10 versus 11 days, respectively). Median overall costs were 16.728 for the hand-assisted laparoscopic procedure and 13.406 for the open procedure (P = 0.095).
                Recovery measured using quality of life questionnaires is comparable for hand-assisted laparoscopic or open restorative proctocolectomy with ileal pouch anal anastomosis. The laparoscopic approach is as safe, but more costly than the open procedure.
The small sample size of included trials together with their methodological weaknesses severely limit the usefulness of this review for guiding practice. It is impossible to identify or refute clinically important differences between the alternative surgical operations. Larger rigorous trials are needed to improve the evidence with which to define optimum surgical treatment for rectal prolapse: the results of one such trial are awaited.