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

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

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:

Study Overview

• Status: Completed
• Conditions: Rectal Prolapse
• Intervention / Treatment: Device: Laparoscopy

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs of improvement	No recurrence of Rectal Prolapse	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs of improvement	Improvement of Fecal Incontinence score(Rintala score)	30 weeks

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2010
• Primary Completion (ACTUAL): January 15, 2015
• Study Completion (ACTUAL): December 18, 2018

Study Registration Dates

• First Submitted: September 28, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (ACTUAL): October 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pediatrics; Mesh; Laparoscopy; Rectal Prolapse; Rectopexy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Rectal Prolapse
• Other Study ID Numbers: Azh-Ped-Surg-70712018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No