Prolapse Pelvic Clinical Trial
— LAPCALLOfficial title:
Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
NCT number | NCT04560543 |
Other study ID # | 2020-01046 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2021 |
Est. completion date | December 2027 |
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.
Status | Recruiting |
Enrollment | 182 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsfrauenklink Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. |
5 years | |
Secondary | Sexual function | Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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