aparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse.
- Conditions
- Pelvic organ prolapse, vault prolapse, laparoscopic sacrocolpopexy, sacrospinous fixation
- Registration Number
- NL-OMON21070
- Lead Sponsor
- Máxima Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Symptomatic vault prolapse POP-Q grade 2 which needs surgical treatment;
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Previous surgical treatment of vault prolapse;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is disease specific quality of life during a follow-up period of one year using the Dutch validated version of the Urinary Distress Inventory (UDI).
- Secondary Outcome Measures
Name Time Method Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, post-operative recovery, procedure related morbidity, sexual function, quality of life, anatomical results using the POP-Q classification until one year follow-up, type and number of re-interventions, costs and cost-effectiveness and long term complications.