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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04560543
Other study ID # 2020-01046
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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