NCT06128291

Brief Summary

Compare the changes of preoperative and postoperative posterior colporrhaphy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

November 7, 2023

Last Update Submit

October 16, 2024

Conditions

Prolapse; Female

Outcome Measures

Primary Outcomes (5)

  • Number of participants with fecal incontinence

    Number of participants present the symptom

    before the operation, postoperative one month and three months.

  • Number of participants with flatus

    Number of patients present the symptom

    before the operation, postoperative one month and three months.

  • Number of participants with constipation

    Number of patients present the symptom

    before the operation, postoperative one month and three months.

  • Number of participants with diarrhea

    Number of patients present the symptom

    before the operation, postoperative one month and three months.

  • Number of participants with sensation of residual stool

    Number of patients present the symptom

    before the operation, postoperative one month and three months.

Study Arms (1)

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

Interventions

posterior colporrhaphyPROCEDURE

posterior colporrhaphy for rectocele.

Posterior colporrhaphy

Eligibility Criteria

Age20 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ho-Hsiung Lin, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

March 3, 2023

Primary Completion

April 3, 2023

Study Completion

December 31, 2023

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

TW(1)