Prophylactic Laparoscopic Suspension After McCall (LAPCALL)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Prolapse Pelvic

Treatments: Procedure: McCall suture; Procedure: Standard cuff closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04560543

2020-01046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups

McCall suture

Experimental group

Description:

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

Treatment:

Procedure: McCall suture

standard cuff closure

Sham Comparator group

Description:

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

Treatment:

Procedure: Standard cuff closure