- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508062
Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms
April 20, 2023 updated by: Gamze Nur Cimilli Şenocak, Ataturk University
Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects
The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation.
Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation.
Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
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
-
-
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Erzurum, Turkey, 25100
- Gamze Nur Cimilli Senocak
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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
23 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients with stage II-IV apical compartment defect according to the POP-Q classification
Exclusion Criteria:
- having severe chronic disease that makes the operation dangerous
- patients under 25 and patients over 75 years old
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: pectopexy group
this group will only have pectopexy operation
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Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
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Active Comparator: Pectopexy and uterosacral ligaments plication group
this group will have pectopexy operation with bilateral uterosacral ligaments plication
|
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
questionnaire of lower urinary tract symptoms
Time Frame: changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
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the questionaire examines these titles by scoring from one to ten points:
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changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
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evaluation of sexual function with Women's Sexual Function Index
Time Frame: changes at the preoperative day 1 and postoperative day 40 period
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Women's Sexual Function Index is a questionnaire about sexual functions of the women.
the index definex sexual functions with some questions and scorings.
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changes at the preoperative day 1 and postoperative day 40 period
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Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Time Frame: changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
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Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
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changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of sexual function with Women's Sexual Function Index
Time Frame: changes at 3,6 and 12. month after surgery
|
Women's Sexual Function Index is a questionnaire about sexual functions of the women.
the index definex sexual functions with some questions and scorings.
|
changes at 3,6 and 12. month after surgery
|
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Time Frame: changes at 3,6 and 12. month after surgery
|
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
|
changes at 3,6 and 12. month after surgery
|
questionnaire of lower urinary tract symptoms
Time Frame: changes in symptoms for each title at 3,6 and 12. month after surgery
|
the questionaire examines these titles by scoring from one to ten points:
|
changes in symptoms for each title at 3,6 and 12. month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gamze Nur Cimilli Senocak, Atatürk University
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)
August 6, 2020
Primary Completion (Actual)
March 6, 2021
Study Completion (Actual)
March 6, 2022
Study Registration Dates
First Submitted
May 29, 2020
First Submitted That Met QC Criteria
August 8, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/6
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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