Transvaginal Versus Transperineal Repair of Rectocele

January 9, 2019 updated by: Sameh Emile, Mansoura University

Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial

Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

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

    • Dakahlia
      • Mansourah, Dakahlia, Egypt
        • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult female patients with anterior rectocele

Exclusion Criteria:

  • Male patients.
  • Combined rectocele with internal rectal prolapse.
  • Anismus.
  • Associated anorectal condition such as hemorrhoids and anal fissure.
  • Pregnancy.
  • Unwilling to participate in the trial

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transvaginal repair
Repair of anterior rectocele via the vagina
Vaginal incision through which plication of the rectovaginal septum is done
Active Comparator: Transperineal repair
Repair of anterior rectocele via the perineum
Perineal incision through which plication of the rectovaginal septum is done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in constipation
Time Frame: 6 and 12 months after surgery
decrease in Wexner constipation score by 25%
6 and 12 months after surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sameh H Emile, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

April 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

January 7, 2019

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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