Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• LSC simple hysterectomy,
• Neg. SS test if premenopausal
• \>18j,
• Consent to participate in the study
• Understanding of the German language
Locations
Other Locations
Switzerland
Universitätsfrauenklink Inselspital
RECRUITING
Bern
Contact Information
Primary
Diana Höhn, MD
diana.hoehn@insel.ch
0316321010
Time Frame
Start Date: 2021-05-15
Estimated Completion Date: 2029-12
Participants
Target number of participants: 182
Treatments
Experimental: McCall suture
Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.
Sham_comparator: standard cuff closure
Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern