Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair
NCT ID: NCT05444023
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-11-15
2024-03-03
Brief Summary
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Detailed Description
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Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.
Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.
The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.
Project design: The investigators will perform an international singlecentre single-blind randomized controlled trial by participating in our tertiary referral hospital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transverse separated suturing technique
During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.
Pubocervical fascia reconstruction
Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.
circular continue suturing technique
During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.
Pubocervical fascia reconstruction
Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.
Interventions
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Pubocervical fascia reconstruction
Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.
Eligibility Criteria
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Inclusion Criteria
* Women aged between 18-75 years of age
Exclusion Criteria
* Inability to comprehend questionnaires
* Inability to give informed consent
* Inability to return for a review
* Prior anterior compartment repair with or without mesh
* Severe cardiovascular or respiratory disease
* Women who don't want anterior compartment repair
* Pregnancy
* Age \<18 years
18 Years
75 Years
FEMALE
Yes
Sponsors
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Kanuni Sultan Suleyman Training and Research Hospital
OTHER
Responsible Party
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Ozan Karadeniz
Principal investigator
Locations
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Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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KanuniSSEAH
Identifier Type: -
Identifier Source: org_study_id
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