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

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.

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.

Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually thereafter till 60 months after surgery.

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.