NCT04560543

Prophylactic Laparoscopic Suspension After McCall

Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prolapse Pelvic

Interventions

Type	Name	Description
PROCEDURE	McCall suture	Laparoscopic suture including the uterosacral ligaments and the peritoneum
PROCEDURE	Standard cuff closure	Standard laparoscopic barbed suture of the vaginal cuff

Timeline

• Start date: 2021-05-15
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2020-09-23
• Last updated: 2024-11-07

Locations

1 site across 1 country: Switzerland