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

NCT ID: NCT04117633

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-01

Study Completion Date

2018-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mesh Rectopexy

Using Laparoscopy

Group Type ACTIVE_COMPARATOR

Laparoscopy

Intervention Type DEVICE

Laparoscopic Procedures for Rectopexy

Suture Rectopexy

Using Laparoscopy

Group Type ACTIVE_COMPARATOR

Laparoscopy

Intervention Type DEVICE

Laparoscopic Procedures for Rectopexy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopy

Laparoscopic Procedures for Rectopexy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

abdelaziz yehya

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Azh-Ped-Surg-70712018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.