Translabial 3D ultrasonography for diagnosing levator defects.
Recruiting
- Conditions
- The lifetime risk for women to be operated because of pelvic organ prolapse (POP) is 11%. In the Netherlands yearly 13.000 patients undergo surgical correction because of pelvic organ prolapse. These operations are known to have a high re-operation rate (30%) because of primary failure and secondary recurrence.
- Registration Number
- NL-OMON27743
- Lead Sponsor
- Maastricht university medical center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
Women with at least POPQ stage II descent of the anterior compartment who are scheduled for colporraphia anterior alone or in combination with other pelvic organ prolapse surgery.
Exclusion Criteria
1. Previous POP surgery;
2. The intention to use mesh-materials;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The diagnostic test characteristics of 3D ultrasonography in diagnosing levator defects compared to MRI.
- Secondary Outcome Measures
Name Time Method 1. Inter-observer agreement in diagnosing levator defects with 3D ultrasonography;<br /><br>2. Determination whether levator defects are an independent risk factor for recurrence after POP surgery;<br /><br>3. Potential cost-effectiveness of introducing 3D ultrasonography for diagnosing levator defects in the work-up of a patient with POP.<br>