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CompletedNCT04117633Updated Oct 8, 2019

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

An interventional study of Laparoscopy in Rectal Prolapse, sponsored by Al-Azhar University. Completed. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-10-08.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 years 7 months after the study started (first participant enrolled Feb 2010, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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:

Read the 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

02

Conditions studied

  • Rectal Prolapse

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Keywords

  • Rectal Prolapse
  • Laparoscopy
  • Mesh
  • Rectopexy
  • pediatrics
03

In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's enrollment of 64 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Children with persistant complete Rectal Prolapse.

  • Failure of conservative treatment.
  • more than 2 attacks of prolapse requiring manual reduction.

Exclusion criteria

Exclusion Criteria:

  • Sever constipation
  • Previous abdominal or pelvic surgery with extensive adhesions.
  • Cases older than 12ys,
  • Patients with rectal polyp
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    Mesh Rectopexy

    Using Laparoscopy

    Device: Laparoscopy

  • Active comparator
    Suture Rectopexy

    Using Laparoscopy

    Device: Laparoscopy

Interventions

  • DeviceLaparoscopy

    Laparoscopic Procedures for Rectopexy

06

What researchers measure

Primary outcomes

  1. Signs of improvement

    No recurrence of Rectal Prolapse

    Time frame: 12 weeks

Secondary outcomes

  1. Signs of improvement

    Improvement of Fecal Incontinence score(Rintala score)

    Time frame: 30 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04117633
Responsible party
abdelaziz yehya (professor, Al-Azhar University) — Principal investigator
First posted
Oct 7, 2019
Start date
Feb 1, 2010
Primary completion
Jan 15, 2015
Completion
Dec 18, 2018
Last update
Oct 8, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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