Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse
- Conditions
- Posterior LaparoscopicRectopexyLateral LaparoscopicComplete Rectal Prolapse
- Interventions
- Procedure: Laproscopic posterior mesh rectopexy (Wells or LPMR)Procedure: Laparoscopic lateral mesh rectopexy (Orr-Loygue)
- Registration Number
- NCT06559085
- Lead Sponsor
- Assiut University
- Brief Summary
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy
- Detailed Description
Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.
Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.
The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.
The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age from 18 to 70 years.
- Both sexes.
- Patients with complete rectal prolapse.
- Unfit for surgery
- Impaired coagulation profile
- Contraindication of laparoscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laproscopic posterior mesh rectopexy (Wells or LPMR) Laproscopic posterior mesh rectopexy (Wells or LPMR) After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported Laparoscopic lateral mesh rectopexy (Orr-Loygue) Laparoscopic lateral mesh rectopexy (Orr-Loygue) This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years.
- Primary Outcome Measures
Name Time Method Operative time Until the conclusion of the surgical procedure Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair)
Intraoperative injuries Until the conclusion of the surgical procedure Intra operative injuries will be recorded including bowel or vascular injuries
- Secondary Outcome Measures
Name Time Method Improving of symptoms 28 days after surgery Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to improving of symptoms will be recorded
Recurrence rate 28 days after surgery Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to recurrence rate will be recorded The recurrence rate was 3% (1/35) after a mean follow-up of 36 months in laparoscopic lateral mesh rectopexy (Orr-Loygue) and recurrence rates ranged from 0% to 11% in laproscopic posterior mesh rectopexy (Wells or LPMR)
Complications 28 days after surgery Complications will be recorded such as early as bleeding, incontinence, intestinal obstruction, late as constipation, sexual dysfunction, intestinal obstruction, erosion of mesh
Trial Locations
- Locations (1)
Assiut university
🇪🇬Assiut, Egypt