Laparoscopic Lateral Suspension Versus Laparoscopic Sacral Colpopexy for Anterior and Apical Prolapse: an International Multicentric Randomized Trial

Background:

Pelvic Organ Prolapse (POP) is a frequent condition and can substantially affect a woman's quality of life. It is widely accepted that POP when defined by symptoms has a prevalence of 3-6 % and up to 50 % when based upon vaginal examination. Only 10 to 20 percent of affected women though seek evaluation for their condition. Although surgery is generally reserved for patients with bothersome prolapse symptoms at an advanced stage after failure of conservative treatments, a woman's lifetime risk of surgery for POP is 12-19%. Given the increasing resources that will be required for POP surgery in the future it is crucial to seek durable, cost effective interventions with minimal morbidity. Various surgical techniques exist for the correction of POP for all three compartments and there is an ongoing debate about whether to favour traditional vaginal techniques or abdominal approaches (either by laparoscopy, robotically-assisted laparoscopy or laparotomy) using synthetic mesh. Despite the 2011 FDA warning concerning POP repair with surgical mesh, transabdominal mesh procedures have not come under severe scrutiny because of more favourable risk-benefit profile. That is why sacrocolpopexy (SCP) is now considered as gold standard for the correction of apical POP and can safely and efficiently be performed laparoscopically or with robotic assistance, subsequently reducing length of hospitalization and recovery time. This technique however requires dissection at the level of the promontory, which can be challenging, particularly in obese women and when anatomical variation exists. Serious neurological or ureteral morbidity as well as life-threatening vascular injury could be the consequence of potential lesions in the sacral area. Moreover, significant dorso-lumbar pain in up to 50% of patients has been described following the use of sutures or tackers at the sacrum and most significantly, up to 30% of patients will suffer from de novo constipation due to injury to the hypogastric nerve during peritoneal dissection. Laparoscopic lateral suspension with mesh (LLS) could represent an alternative procedure, avoiding dissection at the promontory. Previous studies have shown that LLS is comparable in terms of subjective and objective outcome and that women are highly satisfied. Both procedures remain untested against each other under the rigors of a randomized controlled trial.

Hypothesis and primary objective :

The aim of the study will be to compare the SCP and LLS in the management of apical prolapse at 6 weeks, 6 months, 1 year and yearly up to 2 years with the null hypothesis being that no significant differences existed between the two surgical procedures.

Primary and secondary endpoints: