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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03026738
Collaborator
(none)
30
2
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic anterior mesh rectopexy
  • Procedure: Laparoscopic posterior mesh rectopexy
  • Device: polypropylene mesh
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Laparoscopic anterior mesh rectopexy
fixation of the rectum anteriorly using laparosopy and polypropylene mesh

Device: polypropylene mesh
A strip of polypropylene mesh will be introduced and sutured.

Active Comparator: 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.

Procedure: Laparoscopic posterior mesh rectopexy
fixation of the rectum posteriorly using laparosopy and polypropylene mesh

Device: polypropylene mesh
A strip of polypropylene mesh will be introduced and sutured.

Outcome Measures

Primary Outcome Measures

  1. improvement of incontinence and / or constipation. [1 year postoperatively]

  2. recurrence rate [1 year postoperatively]

Secondary Outcome Measures

  1. Duration of Surgery [intraoperative]

    The duration of the procedure will be registered in minutes.

  2. Peri-operative blood loss [during surgery, 1 day]

    Blood loss will be measured in milliliters

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ibrahim Mostafa Ahmed Abdel Aal, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT03026738
Other Study ID Numbers:
  • AssiutU4988
First Posted:
Jan 20, 2017
Last Update Posted:
Jan 20, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2017