Actively Recruiting
Prophylactic Laparoscopic Suspension After McCall
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-07
182
Participants Needed
1
Research Sites
446 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. 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.
CONDITIONS
Official Title
Prophylactic Laparoscopic Suspension After McCall
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned simple laparoscopic hysterectomy
- Negative stress test if premenopausal
- Age over 18 years
- Consent to participate in the study
- Understanding of the German language
You will not qualify if you...
- Prolapse as the indication for surgery
- Known or suspected non-compliance
- Additional incontinence procedures planned
- Deep infiltrating endometriosis
- Pre- or postoperative irradiation
- Pregnancy or lactation
- Transgender individuals
- Conversion from laparoscopy to laparotomy
- Inability to understand the study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitätsfrauenklink Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
D
Diana Höhn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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