Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum. Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04560543
Study type Interventional
Source University Hospital Inselspital, Berne
Contact Diana Höhn, MD
Phone 0316321010
Status Recruiting
Phase N/A
Start date May 15, 2021
Completion date December 2027