NCT04560543 Prophylactic Laparoscopic Suspension After McCall
| NCT ID | NCT04560543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Prolapse Pelvic |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2021-05-15 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2021-05-15 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Michel D Mueller, Prof.
STUDY DIRECTOR
Department of Gynaecology, University Hospital, Berne
Frequently Asked Questions
Who can join the NCT04560543 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Prolapse Pelvic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04560543 currently recruiting?
Yes, NCT04560543 is actively recruiting participants. Contact the research team at diana.hoehn@insel.ch for enrollment information.
Where is the NCT04560543 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT04560543 clinical trial?
NCT04560543 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Michel D Mueller, Prof. at Department of Gynaecology, University Hospital, Berne. The trial plans to enroll 114 participants.