Prophylactic Laparoscopic Suspension After McCall

Prolapse Pelvic Clinical Trial

— LAPCALL  

Official title:

Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560543
• Other study ID #: 2020-01046
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: December 2027

Study information

• Verified date: October 2021
• Source: University Hospital Inselspital, Berne
• Contact: Diana Höhn, MD
• Phone: 0316321010
• Email: diana.hoehn[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Prolapse Pelvic

Intervention

Procedure:
• McCall suture
Laparoscopic suture including the uterosacral ligaments and the peritoneum
• Standard cuff closure
Standard laparoscopic barbed suture of the vaginal cuff

Locations

Country	Name	City	State
Switzerland	Universitätsfrauenklink Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sexual function	Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score	5 years