Preventing pelvic prolapse after hysterectomy using laparoscopic techniques
Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
NA · Insel Gruppe AG, University Hospital Bern · NCT04560543
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT04560543 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old undergoing simple hysterectomy who can provide informed consent and understand German.
Not a fit: Patients with prolapse as an indication for surgery or those requiring additional incontinence procedures will not benefit from this study.
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 performed: While there is limited long-term data on laparoscopic approaches for prolapse prevention, some studies have shown promising anatomic results with similar techniques.
Eligibility criteria
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. * Transgender population * Conversion from laparoscopy to laparotomy * Inability to understand the study protocol
Where this trial is running
Bern
- Universitätsfrauenklink Inselspital — Bern, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Diana Höhn, MD
- Email: diana.hoehn@insel.ch
- Phone: 0316321010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prolapse Pelvic