Prolapse; FemaleNCT06128291
Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair
An observational study of Prolapse; Female, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Compare the changes of preoperative and postoperative posterior colporrhaphy. Read more about this study
- Who is it for?
- Ages 20 to 100 years, women only
- Conditions the study is for
- Prolapse; Female
- What is being tested?
- posterior colporrhaphy
- Type of treatment
- Surgery or procedure
- How many people
- 283 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Mar 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy
Who may be able to join
- women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prolapse; Female
- Being tested
- posterior colporrhaphy
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior colporrhaphyProcedure or surgery
posterior colporrhaphy for rectocele.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: posterior colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with fecal incontinence
Number of participants present the symptom
Measured: before the operation, postoperative one month and three months.
Number of participants with flatus
Number of patients present the symptom
Measured: before the operation, postoperative one month and three months.
Number of participants with constipation
Number of patients present the symptom
Measured: before the operation, postoperative one month and three months.
Number of participants with diarrhea
Number of patients present the symptom
Measured: before the operation, postoperative one month and three months.
Number of participants with sensation of residual stool
Number of patients present the symptom
Measured: before the operation, postoperative one month and three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start3 Mar 2023
- Primary completion3 Apr 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse; FemaleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128291
- Sponsor's protocol ID
- 202303052RINA
- Status last verified
- Oct 2024
- First submitted
- 7 Nov 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Concomitant Posterior Colporrhaphy on Bowel Functions in Women Who Received Pelvic Organ Prolapse Repair
- ClinicalTrials.gov ID
- NCT06128291
- Acronym / sponsor ID
- 202303052RINA
- Conditions
- Prolapse; Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the changes of preoperative and postoperative 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior colporrhaphy | – | Procedure: posterior colporrhaphyMedical records of women received concomitant posterior colporrhaphy for their pelvic organ prolapse repairs. Comparison will be made to compare preoperative and postoperative conditions. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy
Key inclusion criteria (1 listed)
- women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior colporrhaphyposterior colporrhaphy for rectocele. | Procedure or surgery | Posterior colporrhaphy |
Primary outcome
Number of participants with fecal incontinence
Time frame: before the operation, postoperative one month and three months.
Number of participants present the symptom
Number of participants with flatus
Time frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
Number of participants with constipation
Time frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
Number of participants with diarrhea
Time frame: before the operation, postoperative one month and three months.
Number of patients present the symptom
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Hsiung Lin, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse; Female, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with fecal incontinence (time frame: before the operation, postoperative one month and three months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.