Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial).

OBJECTIVE: To investigate whether laparoscopic sacrohysteropexy (LSH) is non-inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse. DESIGN: Multicentre randomised controlled, non-blinded non-inferiority trial. SETTING: Five non-university teaching hospitals in the Netherlands, one university hospital in Belgium. POPULATION: 126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery. METHODS: Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%. MAIN OUTCOME MEASURES: Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life. RESULTS: Laparoscopic sacrohysteropexy was non-inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference -1.7%, 95% CI: -7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP. CONCLUSION: Laparoscopic sacrohysteropexy was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent. TWEETABLE ABSTRACT: Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short-term outcomes.

A uniaxial force and stiffness model of the vagina during laparoscopic sacrocolpopexy.

BACKGROUND: Laparoscopic sacrocolpopexy is the preferred procedure for restoring vaginal vault prolapse. An assistant uses a vaginal manipulator to position and tension the vault such that the surgeon can dissect the bladder, rectum and vault to eventually suture a synthetic mesh used to suspend the vagina to the longitudinal anterior vertebral ligament. Vaginal vault manipulation requires application of high forces for long periods of time. METHODS: This work quantifies the task by measuring and analyzing the interaction forces and the workspace during vaginal vault manipulation. From the measurements we developed a uniaxial model, expressing the increase in interaction force and stiffness of the vagina. By adapting the model parameters, the difference in interaction force and stiffness between moderate and severe prolapse is predicted. FINDINGS: For moderate prolapse the average interaction force and stiffness start at 2.56 N and 0.11 N mm-1 in the tensionfree state, and go up to 20.14 N and 0.53 N mm-1 after complete insertion of the instrument. For severe degrees of prolapse, tissue interaction is much lower starting at 1.68 N and 0.06 N mm-1 while staying limited to 12.20 N and 0.30 N mm-1 at full extension. INTERPRETATION: Population data shows that the stage of prolapse and total vaginal length increase with age and parity. The interaction force and stiffness of the vagina are correlated with this degree of prolapse. By adapting the model parameters a good estimation of the tissue interaction is found for patients with mild and severe prolapse.