No registrations found.
ID
Source
Brief title
Health condition
uterine prolapse, vaginal sacrospinous hysteropexy, laparoscopic sacrohysteropexy
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Randomized 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.
Study objective
In 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.
Study design
Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually thereafter till 60 months after surgery.
Intervention
The 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.
Postbus 10400
M.N. IJsselmuiden, van
Zwolle 8000 GK
The Netherlands
038 424 4692
m.n.van.ijsselmuiden@isala.nl
Postbus 10400
M.N. IJsselmuiden, van
Zwolle 8000 GK
The Netherlands
038 424 4692
m.n.van.ijsselmuiden@isala.nl
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;
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3841 |
| NTR-old | NTR4029 |
| Other | METc Zwolle : 13.0320 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |