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OpenTrials
Completed

NCT Number: NCT04117633

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

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:

Completed

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Key information

Conditions

Rectal Prolapse Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopy

Device

Laparoscopic Procedures for Rectopexy

Primary outcomes

  1. Signs of improvement

    Time frame: 12 weeks

    No recurrence of Rectal Prolapse

Secondary outcomes

  1. Signs of improvement

    Time frame: 30 weeks

    Improvement of Fecal Incontinence score(Rintala score)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2018
First posted
Oct 7, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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