Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.

Not Applicable

• Conditions: Rectal Prolapse
• Interventions: Procedure: Laparoscopic anterior mesh rectopexy; Procedure: Laparoscopic posterior mesh rectopexy; Device: polypropylene mesh

• Registration Number: NCT03026738
• Lead Sponsor: Assiut University

Brief Summary

Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

Detailed Description

Rectal prolapse is a disabling condition, which is more common in females and increases in frequency with age.

There are two types of rectal prolapse; external and internal. External rectal prolapse is a circumferential protrusion of all layers of the rectum through the anal sphincter. Internal rectal prolapse, also referred to as rectal intussusception.

The majority of patients with a RP suffer from symptoms of fecal incontinence and constipation, causing a significant negative impact on quality of life.

The aims of the surgical treatment are to correct the anatomical abnormality and to cure the accompanying symptoms of incontinence, constipation and pain, with the lowest rate of complications as possible and an acceptable rate of recurrence.

Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment for RP have been applied in patients of all ages.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-14
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-20
• Last Update Posted: 2017-01-20
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• all patients with rectal prolapse either external or internal prolapse

Exclusion Criteria

• Age below 18 years.
• Pregnancy or breast-feeding.
• Recurrence of rectal prolapse.
• patients with previous complicated abdominal surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic anterior mesh rectopexy	Laparoscopic anterior mesh rectopexy	A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.
Laparoscopic posterior mesh rectopexy	Laparoscopic posterior mesh rectopexy	Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.
Laparoscopic posterior mesh rectopexy	polypropylene mesh	Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.
Laparoscopic anterior mesh rectopexy	polypropylene mesh	A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.

Primary Outcome Measures

Name	Time	Method
improvement of incontinence and / or constipation.	1 year postoperatively
recurrence rate	1 year postoperatively

Secondary Outcome Measures

Name	Time	Method
Duration of Surgery	intraoperative	The duration of the procedure will be registered in minutes.
Peri-operative blood loss	during surgery, 1 day	Blood loss will be measured in milliliters