Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair

Prolapse; Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06128291
• Other study ID #: 202303052RINA
• Status: Active, not recruiting
• Start date: March 3, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Compare the changes of preoperative and postoperative posterior colporrhaphy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 283
• Est. completion date: December 31, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Prolapse; Female

Intervention

Procedure:
• posterior colporrhaphy
posterior colporrhaphy for rectocele.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with fecal incontinence	Number of participants present the symptom	before the operation, postoperative one month and three months.
Primary	Number of participants with flatus	Number of patients present the symptom	before the operation, postoperative one month and three months.
Primary	Number of participants with constipation	Number of patients present the symptom	before the operation, postoperative one month and three months.
Primary	Number of participants with diarrhea	Number of patients present the symptom	before the operation, postoperative one month and three months.
Primary	Number of participants with sensation of residual stool	Number of patients present the symptom	before the operation, postoperative one month and three months.