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

Primary Purpose

Rectal Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopy
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Prolapse focused on measuring Rectal Prolapse, Laparoscopy, Mesh, Rectopexy, pediatrics

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Mesh Rectopexy

    Suture Rectopexy

    Arm Description

    Using Laparoscopy

    Using Laparoscopy

    Outcomes

    Primary Outcome Measures

    Signs of improvement
    No recurrence of Rectal Prolapse

    Secondary Outcome Measures

    Signs of improvement
    Improvement of Fecal Incontinence score(Rintala score)

    Full Information

    First Posted
    September 28, 2019
    Last Updated
    October 6, 2019
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04117633
    Brief Title
    Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children
    Official Title
    Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2010 (Actual)
    Primary Completion Date
    January 15, 2015 (Actual)
    Study Completion Date
    December 18, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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:
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Prolapse
    Keywords
    Rectal Prolapse, Laparoscopy, Mesh, Rectopexy, pediatrics

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mesh Rectopexy
    Arm Type
    Active Comparator
    Arm Description
    Using Laparoscopy
    Arm Title
    Suture Rectopexy
    Arm Type
    Active Comparator
    Arm Description
    Using Laparoscopy
    Intervention Type
    Device
    Intervention Name(s)
    Laparoscopy
    Intervention Description
    Laparoscopic Procedures for Rectopexy
    Primary Outcome Measure Information:
    Title
    Signs of improvement
    Description
    No recurrence of Rectal Prolapse
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Signs of improvement
    Description
    Improvement of Fecal Incontinence score(Rintala score)
    Time Frame
    30 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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