aparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse
Recruiting
- Conditions
- vrouwelijke geslachtsorganen: bekkenbodemPelvic organ prolapse
- Registration Number
- NL-OMON47730
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 106
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Symptomatic vault prolapse POP-Q grade 2 which needs surgical treatment
- Eligible for both surgical treatments
- Patients must be able to read Dutch
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous surgical treatment of vault prolapse
- Contra-indication for a surgical intervention
- Incapacitated patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is disease specific quality of life at one year follow-up<br /><br>using the Dutch validated version of the Urinary Distress Inventory (UDI).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome will be the effect of the surgical treatment on prolapse<br /><br>related symptoms, post-operative recovery, procedure related morbidity, sexual<br /><br>function, quality of life, anatomical results using the POP-Q classification at<br /><br>one and five years follow-up, type and number of re-interventions, costs and<br /><br>cost-effectiveness and long term complications. </p><br>