Prophylactic Laparoscopic Suspension After McCall

Not Applicable

Recruiting

• Conditions: Prolapse Pelvic
• Interventions: Procedure: Standard cuff closure; Procedure: McCall suture

• Registration Number: NCT04560543
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2021-05-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard cuff closure	Standard cuff closure	Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)
McCall suture	McCall suture	Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.

Primary Outcome Measures

Name	Time	Method
Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm.	5 years	Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years.; Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen.

Secondary Outcome Measures

Name	Time	Method
Sexual function	5 years	Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score

Trial Locations

Locations (1)

Universitätsfrauenklink Inselspital; 🇨🇭 Bern, Switzerland