Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
NCT ID: NCT03113513
Last Updated: 2024-01-23
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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ACTIVE_NOT_RECRUITING
NA
312 participants
INTERVENTIONAL
2016-05-01
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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McCall culdoplasty
The McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks.
fixation of the vaginal apex
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
Sacrospinous ligament fixation
The SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff.
fixation of the vaginal apex
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
Interventions
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fixation of the vaginal apex
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
Eligibility Criteria
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Inclusion Criteria
* planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
* any symptomatic POP or stage II prolapse in any compartment
* at least stage I prolapse in the apical department
* women between 35 and 80 years of age
* good German language skills
* any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
* concomitant salpingo-oophorectomy if indicated
Exclusion Criteria
* Neurological disorders
* Previous hysterectomy
* Desire to have children
* Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
35 Years
80 Years
FEMALE
Yes
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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MUGRAZ
Graz, Styria, Austria
Countries
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References
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Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.
Other Identifiers
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V4 31.01.2016
Identifier Type: -
Identifier Source: org_study_id
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