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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 114 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | May 15, 2021 |
| Main results expected | April 30, 2027 |
| Study ends | December 31, 2032 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT04560543 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
- Study coordinator: Diana Höhn, MD
- Email: diana.hoehn@insel.ch
- Phone: 0316321010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.