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NCT04117633 Clinical Trial

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

Rectal Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04117633
Other study ID # Azh-Ped-Surg-70712018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2010
Est. completion date December 18, 2018

Study information
Verified date October 2019
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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:

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

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date December 18, 2018
Est. primary completion date January 15, 2015
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Laparoscopy
Laparoscopic Procedures for Rectopexy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Outcome
Type Measure Description Time frame Safety issue
Primary Signs of improvement No recurrence of Rectal Prolapse 12 weeks
Secondary Signs of improvement Improvement of Fecal Incontinence score(Rintala score) 30 weeks
See also
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