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The LAVA-trial: hysteropexy in treatment of uterine prolape stage ≥ 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy


- candidate number14974
- NTR NumberNTR4029
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2013
- Secondary IDs13.0320 METc Zwolle
- Public TitleThe LAVA-trial: hysteropexy in treatment of uterine prolape stage ≥ 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy
- Scientific TitleHysteropexy in treatment of uterine prolape stage ≥ 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy
- ACRONYMLAVA trial
- hypothesisIn the treatment of uterine prolapse stage 2 or higher, the laparoscopic sacrohysteropexy will be equal or more successful in correction of uterine prolapse (lower recurrence rate) as compared to vaginal sacrospinous fixation.
- Healt Condition(s) or Problem(s) studiedUterine prolapse, Laparoscopic sacrohysteropexy, Vaginal sacrospinous hysteropexy
- Inclusion criteriaWomen with uterine prolapse stage ≥ 2 requiring surgical treatment
- Exclusion criteria1. Contraindications of laparoscopic surgery;
2. Previous pelvic floor or prolapse surgery;
3. Known malignancy or abnormal cervical smears;
4. Unwilling to return for follow-up or language barriers;
5. Wish to preserve fertility;
6. Presence of immunological/haematological disorders interfering with recovery after surgery;
7. Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-dec-2019
- Target number of participants124
- InterventionsThe LAVA-trial compares the vaginal sacrospinous hysteropexy to the laparoscopic sacrohysteropexy in the treatment of uterine descent. In the vaginal sacrospinous hysteropexy, the uterus is suspended to the sacrospinous ligaments with permanent sutures. In the laparoscopic sacrohysteropexy, the uterus is elevated by attaching the cervix to the sacral promontory, using a mesh. Both procedures are used in correcting uterine descent. Eligible women will be randomly allocated to receive either a laparoscopic sacrohysteropexy or a vaginal sacrospinous hysteropexy. The vaginal procedure can be performed under general or spinal anaesthesia, according to the preference of patient and anaesthesiologist. The laparoscopic procedure will be performed under general anaesthesia. Post-operative follow-up will take place after 6 weeks, 6 months, 12 months and annually thereafter until 5 years. Patients will undergo a standard gynecological examination (including a POP-Q examination) and fill in questionnaires.
- Primary outcomeAnatomical outcome and recurrence rate assessed by the POP-Q test at 1 and 5 years follow-up. Recurrence rate is defined as uterine prolapse ≥ 2 with symptoms.
- Secondary outcomeSubjective 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.
- TimepointsEvaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually thereafter till 60 months after surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.N. IJsselmuiden, van
- CONTACT for SCIENTIFIC QUERIES M.N. IJsselmuiden, van
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- PublicationsN/A
- Brief summaryRandomized controlled trial to study the effects of laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy, on prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery, sexual functioning and costs.
- Main changes (audit trail)
- RECORD9-jun-2013 - 21-jul-2013


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