Prophylactic Laparoscopic Suspension After McCall

NCT04560543 | Recruiting

• 1 other identifier: 2020-01046
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolapse Pelvic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sexual function

  5 years

Study Arms (2)

McCall suture

EXPERIMENTAL

Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.

Procedure: McCall suture

standard cuff closure

SHAM COMPARATOR

Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)

Procedure: Standard cuff closure

Interventions

McCall suture PROCEDURE

Laparoscopic suture including the uterosacral ligaments and the peritoneum

Also known as: Uterosacral Ligament Suspension

McCall suture

Standard cuff closure PROCEDURE

Standard laparoscopic barbed suture of the vaginal cuff

standard cuff closure

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Universitätsfrauenklink Inselspital

Bern, 3010, Switzerland

RECRUITING

Study Officials

• Michel D Mueller, Prof.

  Department of Gynaecology, University Hospital, Berne

  STUDY DIRECTOR

Central Study Contacts

Diana Höhn, MD

CONTACT

0316321010; diana.hoehn@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: May 15, 2021
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)