A randomized clinical trial comparing primary overlap with approximation repair of third-degree obstetric tears. Direct repair vs. overlapping sphincter repair: a randomized, controlled trial. Randomized controlled trial between perineal and anal repairs of rectocele in obstructed defecation. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. Randomized trial comparing three forms of pelvic floor repair for neuropathic faecal incontinence. Comparison of controlled-intermittent anal dilatation and lateral internal sphincterotomy in the treatment of chronic anal fissures: a prospective, randomized study. Comparison of J-pouch and coloplasty pouch for low rectal cancers: a randomized, controlled trial investigating functional results and comparative anastomotic leak rates. Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm. A study of fecal incontinence in patients with chronic anal fissure: prospective, randomized, controlled trial of the extent of internal anal sphincter division during lateral sphincterotomy.
We compared, in a prospective, randomized clinical trial, the subjective and objective outcomes after primary anal sphincter overlap or approximation repair of third-degree obstetric tears.
                In a prospective, randomized clinical trial at our university teaching hospital, we studied 112 primiparous women who sustained a third-degree tear during a 1-year period (July 1998-June 1999); they were randomly selected, at diagnosis, to receive either an overlap or an approximation repair. Obstetric personnel, trained in both methods, carried out the repairs immediately after delivery. Fifty-five women underwent an overlap procedure, and 57 women underwent an approximation repair. Outcome measures assessed were symptoms of fecal incontinence, abnormal findings on anal manometry, and abnormal findings on endoanal ultrasonography at 3 months post partum.
                Obstetric factors, including mode of delivery, birth weight, duration of labor, and episiotomy incidence, did not differ significantly between the 2 groups. Experience of the operator, analgesia used, and place of repair were similar in both groups. The median incontinence scores were 0/20 after overlap repair and 2/20 after approximation repair (difference not significant). Eleven women (20%) complained of fecal urgency after overlap repair, in comparison with 17 (30%) after approximation repair (difference not significant). There were no significant differences in either anal manometry or endoanal ultrasonographic results between the 2 groups. Six women (11%) had a significant (>1 quadrant) anal sphincter defect after primary overlap repair, compared with 3 (5%) after approximation repair (difference not significant). Overall, 66% of women had ultrasonographic evidence of a residual full-thickness defect in the external anal sphincter after primary repair.
                The outcome after primary repair of third-degree obstetric tear was similar whether an approximation or an overlap technique was used. Overall symptomatic outcome was good, although two thirds of women had ultrasonographic evidence of residual anal sphincter damage irrespective of the method of repair. The aim of this study was to compare the results of two surgical techniques (direct end-to-end vs. overlapping) of delayed repair of a localized anterior defect of external anal sphincter after an obstetric trauma.
                During a five-year period, 23 patients were randomly assigned to direct end-to-end repair (n = 12) or overlapping sphincter repair (n = 11), using 2-0 PDS sutures. Two patients from each group had an internal anal sphincter defect that also was repaired. All patients had a normal pudendal nerve terminal motor latency preoperatively. Evaluations included endoanal ultrasound, anorectal manometry, and neurophysiologic evaluation. Continence was assessed by the Cleveland Clinic Continence Score (0-20; 0, perfect continence; 20, complete incontinence).
                The two groups were comparable with regard to age (median, 45 years), past history of sphincter repair (n = 2), and posterior vaginal repair. There was no major morbidity. The wound-healing rate was identical between the two groups. However, of the patients undergoing overlapping repair, two had fecal impaction, and one had a urinary retention. Median preoperative continence score was 17 in both the direct-repair group (score, 8-20) and the overlap group (score, 7-20). At a median follow-up of 18 months, the improvement in continence was similar between the two surgical groups, with a median continence score of 3, respectively. In both surgical groups there was a significant and similar improvement in maximum squeeze pressure and in the functional anal canal length postoperatively (P < 0.05), but the mean resting pressure was relatively unchanged. In the overlap group, one patient developed a unilaterally prolonged pudendal nerve terminal motor latency that was persistent 22 months after surgery, and two patients had impaired fecal evacuation postoperatively.
                This randomized, controlled study suggests that the outcome is similar whether direct end-to-end or overlapping repair of a sphincter defect is performed. Overlapping repair might be associated with more difficulties with fecal evacuation and a prolonged pudendal nerve terminal motor latency postoperatively. The present study was designed to evaluate functional outcome of perineal repair with and without levatorplasty versus transanal repair of rectocele in obstructed defecation.
                A total of 48 multiparous women with obstructed defecation caused by a rectocele were randomly allocated to three groups: transperineal repair with levatorplasty (TPR-LP; n = 16); transperineal repair without levatorplasty (TPR; n = 16); and transanal repair (TAR; n = 16). The study included defecographic assessment, anal manometry, symptom improvement, sexual function, and score on a function questionnaire. Assessments were done preoperatively and 6 months postoperatively.
                Defecography showed significant reduction in size of rectocele in all groups. Constipation improved significantly in both groups with transperineal repair but not in the group with transanal repair. Significant reductions in mean anal resting pressure, maximum reflex volume, and urge-to-defecate volume were observed only with the transperineal approach (with and without levatorplasty). Functional score improved significantly in the transperineal groups (with levatorplasty, P < 0.001; without levatorplasty, P < 0.01), but not in the transanal group (P = 0.142). Levatorplasty added to transperineal repair significantly improved the overall functional score compared with transperineal repair alone (P < 0.01) and transanal repair TAR (P < 0.001).
                Rectocele repair appears to improve anorectal function by improving rectal urge sensitivity. Transperineal repair of rectocele is superior to transanal repair in both structural and functional outcome. Levatorplasty improves functional outcome, but potential effects on dyspareunia should be discussed with the patient. To compare anterior colporrhaphy with a trocar-guided transobturator mesh procedure (Avaulta(®) anterior).
                Randomised, controlled trial.
                Three teaching hospitals.
                Women with a symptomatic cystocele at least stage II requiring primary surgical correction.
                A total of 125 women were assessed at baseline and 1-year follow up. A sacrospinous hysteropexy or posterior colporrhaphy was performed when indicated.
                The primary outcome was the difference in anatomical cure (defined as Pelvic Organ Prolapse-Quantification <stage II cystocele). Secondary outcomes were complications, self-reported urogenital symptom severity, and quality of life, as measured with validated questionnaires.
                In all, 64 women were allocated to the anterior colporrhaphy group and 61 to the mesh group; 58/64 women versus 56/61 completed 12 months of follow-up analysis. Compared with the anterior colporrhaphy group, the mesh reduced the risk of anatomical failure at 12 months follow up from 59 to 9% (risk reduction 50.3%, 95% CI 35.5-65.1). Only three (5%) re-operations for anatomical failure in the anterior colporrhaphy group were performed versus 0% in the mesh group. Functional outcome improved significantly at 12 months on almost all domains, with similar results between groups. Mesh exposure occurred in two (4%) women. Baseline dyspareunia disappeared significantly more often after an anterior colporrhaphy (80%) than in the mesh group (20%). There was a trend towards more de novo dyspareunia in the mesh group (15% versus 9%).
                Primary cystocele repair with trocar-guided transobturator mesh resulted in a statistically significant better anatomical outcome compared with the anterior colporrhaphy. However, functional outcome was similar between groups.
                © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG. A randomized controlled trial in women with neuropathic faecal incontinence compared total pelvic floor repair (n = 12) with anterior levatorplasty and sphincter plication alone (n = 12) and postanal repair alone (n = 12). Review at 6 and 24 months indicated that results were significantly better for total pelvic floor repair than either of the other procedures. Complete continence was achieved in eight of the 12 patients 2 years after total pelvic floor repair. Only total repair significantly elongated the anal canal. Both total pelvic floor repair and anterior levatorplasty improved sensation in the upper anal canal. The results of controlled-intermittent anal dilatation (CIAD) or lateral internal sphincterotomy (LIS) in the treatment of chronic anal fissures are presented.
                Forty patients who were randomized to two groups underwent CIAD or a LIS. The pre- and post-operative mean anal canal resting pressures (MACRPs) and symptoms were recorded and the results were compared.
                Two months post-operatively, 18 patients in the CIAD group and 17 patients in the LIS group had healed completely, and had no anal incontinence or other complications. The post-operative improvement in pain, bleeding, and constipation did not differ significantly between the two groups. In the CIAD and LIS groups, the pre-operative MACRPs were 89.7+/-16.5 and 87.6+/-12.3 mmHg, respectively; 2 months post-operatively, the MACRPs had significantly decreased to 76.9+/-13.7 and 78.1+/-11.3 mmHg in the CIAD and LIS groups, respectively. No statistical difference existed in the pre- or post-treatment MACRPs between the groups.
                CIAD applied with a standardized technique reduced anal canal resting pressure and provided symptomatic healing that was equivalent to a LIS. Since there were no findings of incontinence, or situations which resulted in sphincter damage, we conclude that CIAD is suitable for patients with chronic anal fissures because it is less invasive than LIS, with equivalent efficacy and safety. In addition, the CIAD method may be an alternative procedure in older and multiparous women who has a higher risk of incontinence. To assess the efficacy of a novel coloplasty colonic pouch design in optimizing bowel function after ultralow anterior resection.
                A colonic J-pouch may reduce excessive stool frequency and incontinence after anterior resection, but at the risk of evacuation problems. Experimental surgery on pigs has suggested that a coloplasty pouch (CP) may be a useful alternative. Although CP has recently been shown to be feasible in patients, there is no randomized controlled trial comparing bowel function with the J-pouch.
                After anterior resection for cancer, patients were allocated to either J-pouch or CP-anal anastomoses. Continence scoring, anorectal manometry, and endoanal ultrasound assessments were made before surgery. All complications were recorded, and these preoperative assessments were repeated at 4 months. The assessments were repeated again at 1 year, and a quality of life questionnaire was added.
                Eighty-eight patients were recruited from October 1998 to April 2000. Both groups were well matched for age, gender, staging, adjuvant therapy, and mean follow-up. There were no differences in the intraoperative time and hospital stay. CP resulted in more anastomotic leaks. At 4 months, J-pouch patients had 10.3% less stool fragmentation but poorer stool deferment and more nocturnal leakage. However, there were no differences in the bowel function, continence score, and quality of life at 1 year. There were no differences in the anorectal manometry and endoanal ultrasound findings.
                Coloplasty pouches resulted in more anastomotic leaks and minimal differences in bowel function. At present, the J-pouch remains the benchmark for routine clinical practice, and due care (including defunctioning stoma) should be exercised in situations requiring CP. We compared long-term health-related quality-of-life outcome after randomization to immediate elective repair or imaging surveillance, and in relation to time of elective repair, in patients with small asymptomatic abdominal aortic aneurysm (AAA).
                This randomized clinical trial was carried out in 16 Veterans Affairs medical centers. Study subjects were patients at good surgical risk, aged 50 to 79 years, with AAAs 4.0 to 5.4 cm in diameter. Interventions included immediate open surgical AAA repair or imaging surveillance every 6 months with repair reserved for AAAs that became symptomatic or enlarged to 5.5 cm. Main outcome measures considered were SF-36 health status questionnaire, prevalence of impotence, and maximum activity level, which were determined at randomization and at all follow-up visits.
                Eleven hundred thirty-six patients were randomized and followed up for 3.5 to 8 years (mean, 4.9 years). The two randomized groups did not differ significantly for most SF-36 scales at most times, but the immediate repair group scored higher overall in general health (P <.0001), which was particularly evident in the first 2 years after randomization, and slightly lower in vitality (P <.05). The baseline value of one SF-36 scale, physical functioning, was an independent predictor of mortality. Overall, more patients became impotent after randomization to immediate repair compared with surveillance (P <.03), but this difference did not become apparent until more than 1 year after randomization. Maximum activity level did not differ significantly between the two randomized groups, but decline over time was significantly greater in the immediate repair group (P <.02).
                For most quality-of-life measures and times there was no difference between randomized groups. Immediate repair resulted in a higher prevalence of impotence more than 1 year after randomization, but was also associated with improved perception of general health in the first 2 years. Troublesome fecal incontinence following a lateral internal sphincterotomy is often attributed to faulty surgical technique. However, it may be associated with coexisting occult sphincter defects. Whether continence is related to the extent of sphincterotomy remains debatable. The aim of the study is to identify fecal incontinence related to chronic anal fissure before and after lateral internal sphincterotomy and its relationship to the extent of internal anal sphincter division.
                One hundred eight patients with chronic anal fissure were prospectively studied before and after lateral internal sphincterotomy. A questionnaire was completed for each patient before and after surgery with regard to any degree of fecal incontinence. Fecal incontinence severity index was assessed using the Cleveland Clinic Incontinence Score. The patients with preoperative perfect continence were randomized into two groups (46 patients in each group): Group 1 underwent traditional lateral internal sphincterotomy (up to the dentate line) and Group 2 were underwent a conservative internal anal sphincterotomy (up to the height of the fissure apex or just below it).
                Minor degrees of incontinence were present before surgery in 16 patients (14.8%). Results of the randomized trial revealed that temporary postoperative incontinence was newly developed in 6/92 of patients (6.52 %) who did not have it before surgery. Five of the six (10.86%) were in Group 1 one (2.17%) was in Group 2 (p = 0.039). Persistent incontinence occurred in two in Group 1 (4.35%). All of them were females. All have had a history of one or more vaginal deliveries.
                A mild degree of fecal incontinence may be associated with chronic anal fissure at presentation rather than as a result of internal sphincterotomy. Troublesome fecal incontinence after lateral internal sphincterotomy is uncommon. Sphincterotomy up to the dentate line provided faster pain relief and faster anal fissure healing, but it was associated with a significant postoperative alteration in fecal incontinence than was sphincterotomy up to the fissure apex. Care should be exercised in female patients with a history of previous obstetric trauma, as internal anal sphincter division may further compromise sphincter function.
The limited data available show that compared to immediate primary end-to-end repair of OASIS, early primary overlap repair appears to be associated with lower risks for faecal urgency and anal incontinence symptoms. As the experience of the surgeon is not addressed in the three studies reviewed, it would be inappropriate to recommend one type of repair in favour of another.
[Note: The six citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]