Prophylactic Laparoscopic Suspension After McCall (LAPCALL)

I

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

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

Trial contacts and locations

0

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Central trial contact

Diana Höhn, MD

Data sourced from clinicaltrials.gov

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