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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RECRUITING
NA
182 participants
INTERVENTIONAL
2021-05-15
2029-12-31
Brief Summary
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The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.
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Detailed Description
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Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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McCall suture
Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.
McCall suture
Laparoscopic suture including the uterosacral ligaments and the peritoneum
standard cuff closure
Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)
Standard cuff closure
Standard laparoscopic barbed suture of the vaginal cuff
Interventions
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McCall suture
Laparoscopic suture including the uterosacral ligaments and the peritoneum
Standard cuff closure
Standard laparoscopic barbed suture of the vaginal cuff
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Neg. SS test if premenopausal
* \>18j,
* Consent to participate in the study
* Understanding of the German language
Exclusion Criteria
* Known or suspected non-compliance
* Additional incontinence procedures
* Patients with deep infiltrating endometriosis
* Irradiation pre- or postoperative
* Pregnancy and lactation.
* Transgender population
* Conversion from laparoscopy to laparotomy
* Inability to understand the study protocol
18 Years
FEMALE
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Michel D Mueller, Prof.
Role: STUDY_DIRECTOR
Department of Gynaecology, University Hospital, Berne
Locations
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Universitätsfrauenklink Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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2020-01046
Identifier Type: -
Identifier Source: org_study_id
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