Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair

October 16, 2024 updated by: National Taiwan University Hospital

The Impact of Concomitant Posterior Colporrhaphy on Bowel Functions in Women Who Received Pelvic Organ Prolapse Repair

Compare the changes of preoperative and postoperative posterior colporrhaphy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Concomitant posterior colporrhaphy was frequently used during pelvic organ prolapse repair.

Objectives:

To evaluate the correlation between the presence of bowel symptoms and s rectocele severity and elucidate the impact of posterior colporrhaphy on bowel functions.

Methods:

Medical records of all consecutive women who received concomitant posterior colporrhaphy for their pelvic organ prolapse repairs were reviewed. In general, all women were requested to answer bowel incontinence assessment questionnaires before and after surgery.

Possible results:

Differences in rectocele severities between the presence or absence of fecal incontinence, flatus incontinence, constipation, diarrhea or sensation of residual stool will be shown.

Study Type

Observational

Enrollment (Actual)

283

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

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan 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

Sampling Method

Non-Probability Sample

Study Population

women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy

Description

Inclusion Criteria:

  • women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy

Exclusion Criteria:

  • Pregnancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Posterior colporrhaphy
Medical records of women received concomitant posterior colporrhaphy for their pelvic organ prolapse repairs. Comparison will be made to compare preoperative and postoperative conditions.
Procedure: posterior colporrhaphy
posterior colporrhaphy for rectocele.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with fecal incontinence
Time Frame: before the operation, postoperative one month and three months.
Number of participants present the symptom
before the operation, postoperative one month and three months.
Number of participants with flatus
Time Frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
before the operation, postoperative one month and three months.
Number of participants with constipation
Time Frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
before the operation, postoperative one month and three months.
Number of participants with diarrhea
Time Frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
before the operation, postoperative one month and three months.
Number of participants with sensation of residual stool
Time Frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
before the operation, postoperative one month and three months.

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ho-Hsiung Lin, MD, PhD, National Taiwan University Hospital

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)

March 3, 2023

Primary Completion (Actual)

April 3, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202303052RINA

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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