The LAVA-trial: hysteropexy in treatment of uterine prolape stage ≥ 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy
- Conditions
- uterine prolapse, vaginal sacrospinous hysteropexy, laparoscopic sacrohysteropexy
- Registration Number
- NL-OMON24294
- Lead Sponsor
- Isala Klinieken Zwolle
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
Women with uterine prolapse stage ≥ 2 requiring surgical treatment
Exclusion Criteria
1. Contraindications of laparoscopic surgery;
2. Previous pelvic floor or prolapse surgery;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The composite primary study outcome of this study is surgical success at 1 and 5 years follow-up. Surgical success is defined as 1) position of the cervix at or above the mid-vagina (C < -TVL/2), 2) no bothersome bulging/protrusion symptoms and 3) no repeat surgery or pessary use for recurrent apical prolapse. Failure in one or more of these three areas constitute a failure.
- Secondary Outcome Measures
Name Time Method Subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness.