Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06128291
• Collaborator: (none)
• Enrollment: 283
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 28.4

Study Details

Study Description

Brief Summary

Compare the changes of preoperative and postoperative posterior colporrhaphy.

Condition or Disease	Intervention/Treatment	Phase
Prolapse; Female	Procedure: posterior colporrhaphy

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 Design

• Study Type: Observational
• Actual Enrollment: 283 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: The Impact of Concomitant Posterior Colporrhaphy on Bowel Functions in Women Who Received Pelvic Organ Prolapse Repair
• Actual Study Start Date: Mar 3, 2023
• Actual Primary Completion Date: Apr 3, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Fecal symptoms [before the operation, postoperative one month and three months.]

   Fecal incontinence, constipation, diarrhea, or sensation of residual stool

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT06128291
• Other Study ID Numbers: 202303052RINA
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Nov 13, 2023