Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial

January 28, 2025 updated by: Mostafa shalaby, MD, MSc, PhD, Mansoura University
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: all required

  • female patients
  • symptomatic rectocele
  • failed conservative treatments for at least 3 months
  • anterior rectocele larger than 3 cm in size in defecogram.
  • retention of the contrast in the rectocele on defecography
  • obstructed defecation manifestations: excessive straining, a sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia

Exclusion Criteria:

  • significant urinary manifestations due to anterior vaginal wall prolapse
  • recurrent rectocele
  • previous anal surgery
  • slow-transit constipation
  • faecal incontinence (FI)
  • abnormal thyroid functions
  • patients under systemic steroid treatment
  • patients with connective tissue disease
  • ASA classification >3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transvaginal repair & botulinum toxin type A toxin injection
Drug: Transvaginal repair & botulinum toxin type A injection
100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
Placebo Comparator: Transvaginal repair & distilled water injection
Procedure: Transvaginal repair & distilled water injection
A total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.21.03.441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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