Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT04117633

Collaborator

(none)

Enrollment

Arms

106.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse	Device: Laparoscopy	N/A

Detailed Description

Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 15, 2015

Actual Study Completion Date :

Dec 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mesh Rectopexy Using Laparoscopy	Device: Laparoscopy Laparoscopic Procedures for Rectopexy
Active Comparator: Suture Rectopexy Using Laparoscopy	Device: Laparoscopy Laparoscopic Procedures for Rectopexy

Arm

Intervention/Treatment

Active Comparator: Mesh Rectopexy

Using Laparoscopy

Device: Laparoscopy

Laparoscopic Procedures for Rectopexy

Active Comparator: Suture Rectopexy

Using Laparoscopy

Device: Laparoscopy

Laparoscopic Procedures for Rectopexy

Outcome Measures

Primary Outcome Measures

Signs of improvement [12 weeks]
No recurrence of Rectal Prolapse

Secondary Outcome Measures

Signs of improvement [30 weeks]
Improvement of Fecal Incontinence score(Rintala score)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children with persistant complete Rectal Prolapse.

Failure of conservative treatment.
more than 2 attacks of prolapse requiring manual reduction.

Exclusion Criteria:

Sever constipation
Previous abdominal or pelvic surgery with extensive adhesions.
Cases older than 12ys,
Patients with rectal polyp

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

abdelaziz yehya, professor, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT04117633

Other Study ID Numbers:

Azh-Ped-Surg-70712018

First Posted:

Oct 7, 2019

Last Update Posted:

Oct 8, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by abdelaziz yehya, professor, Al-Azhar University

Additional relevant MeSH terms:

Rectal Prolapse

Prolapse

Study Results

No Results Posted as of Oct 8, 2019