Prophylactic Laparoscopic Suspension After McCall (LAPCALL)

Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome

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.

Study Overview

• Status: Recruiting
• Conditions: Prolapse Pelvic
• Intervention / Treatment: Procedure: McCall suture; Procedure: Standard cuff closure

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 Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana Höhn, MD; Phone Number: 0316321010 0316321010; Email: diana.hoehn@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Universitätsfrauenklink Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria

• LSC simple hysterectomy,
• Neg. SS test if premenopausal
• >18j,
• Consent to participate in the study
• Understanding of the German language

Exclusion criteria

• Prolapse as indication for surgery
• Known or suspected non-compliance
• Additional incontinence procedures
• Patients with deep infiltrating endometriosis
• Irradiation pre- or postoperative
• Pregnancy and lactation.
• Transgender population
• Conversion from laparoscopy to laparotomy
• Inability to understand the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: McCall suture; Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.	Procedure: McCall suture; Laparoscopic suture including the uterosacral ligaments and the peritoneum; Other Names: Uterosacral Ligament Suspension
Sham Comparator: standard cuff closure; Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)	Procedure: Standard cuff closure; Standard laparoscopic barbed suture of the vaginal cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual function	Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score	5 years

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Director: Michel D Mueller, Prof., Department of Gynaecology, University Hospital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 2020-01046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No