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NCT Number: NCT04560543

Prophylactic Laparoscopic Suspension After McCall

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.

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Key information

Conditions

Prolapse Pelvic

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsfrauenklink Inselspital

Bern, 3010, Switzerland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Conversion from laparoscopy to laparotomy
  • Inability to understand the study protocol

Treatment and study plan

McCall suture

Procedure

Laparoscopic suture including the uterosacral ligaments and the peritoneum

Other names: Uterosacral Ligament Suspension

Standard cuff closure

Procedure

Standard laparoscopic barbed suture of the vaginal cuff

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.

    Time frame: 5 years

    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.

Secondary outcomes

  1. Sexual function

    Time frame: 5 years

    Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Höhn, MD

CONTACT

[email protected]

0316321010 ext. 0316321010

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome

Acronym: LAPCALL

Important dates

Study start
2021
Primary completion
2027
Study completion
2032
First posted
Sep 23, 2020
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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