Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Preventing pelvic prolapse after hysterectomy using laparoscopic techniques

Official title: Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome

Run by Insel Gruppe AG, University Hospital Bern · NCT04560543 · Data updated 2026-11-12

This study is testing if a special stitching method used during laparoscopic surgery can better prevent pelvic prolapse after a hysterectomy compared to the usual stitching method.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment114 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Locations1 site (Bern)
StatusRecruiting
StartedMay 15, 2021
Main results expectedApril 30, 2027
Study endsDecember 31, 2032
Registry record updatedMay 19, 2026
Trial IDNCT04560543 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women over 18 years old undergoing simple hysterectomy who can provide informed consent and understand German.

Probably not a fit

Patients with prolapse as an indication for surgery or those requiring additional incontinence procedures will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the laparoscopic McCall suture compared to standard vaginal cuff closure in preventing pelvic prolapse after simple hysterectomy. A total of 182 patients will be randomly assigned to receive either the McCall suture or the standard closure method, with the randomization process conducted in a double-blinded manner. Follow-up assessments will measure pelvic organ prolapse using the POP-Q system at 6 weeks and annually for up to 5 years. The study seeks to provide long-term data on the effectiveness of this laparoscopic approach.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical techniques that significantly reduce the risk of pelvic prolapse in women undergoing hysterectomy.

How similar studies have gone: While there is limited long-term data on laparoscopic approaches for prolapse prevention, some studies have shown promising anatomic results with similar techniques.

Who can join: the full rules

Show full inclusion / 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.
* Conversion from laparoscopy to laparotomy
* Inability to understand the study protocol

Where it's running

  • Universitätsfrauenklink Inselspital
    Bern, Switzerland
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.