NCT04117633

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:

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2015

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

September 28, 2019

Last Update Submit

October 6, 2019

Conditions

Rectal Prolapse

Keywords

Rectal ProlapseLaparoscopyMeshRectopexypediatrics

Outcome Measures

Primary Outcomes (1)

  • Signs of improvement

    No recurrence of Rectal Prolapse

    12 weeks

Secondary Outcomes (1)

  • Signs of improvement

    30 weeks

Study Arms (2)

Mesh Rectopexy

ACTIVE COMPARATOR

Using Laparoscopy

Device: Laparoscopy

Suture Rectopexy

ACTIVE COMPARATOR

Using Laparoscopy

Device: Laparoscopy

Interventions

LaparoscopyDEVICE

Laparoscopic Procedures for Rectopexy

Mesh RectopexySuture Rectopexy

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with persistant complete Rectal Prolapse.
  • Failure of conservative treatment.
  • more than 2 attacks of prolapse requiring manual reduction.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Prolapse

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 28, 2019

First Posted

October 7, 2019

Study Start

February 1, 2010

Primary Completion

January 15, 2015

Study Completion

December 18, 2018

Last Updated

October 8, 2019

Record last verified: 2019-10