Abdominal Minimally Invasive Surgery (A-MIS), which is performed by minimally invasive approach such as laparoscopic, mini-laparoscopic and robotic has become widely used for advanced or multicompartmental prolapse treatment. Likewise, Abdominal Sacral Colpopexy (ASC) is considered the gold-standard for multicompartmental or advanced prolapse treatment. However, alternative surgical strategies, such as Abdominal Lateral Suspension (ALS) with mesh, have been developed in order to avoid the anatomical threats of suspension to the sacrum (1-2).
The aim of this study is to compare the gold-standard treatment for apical prolapse (ASC) with the recent surgical strategy (ALS) in term of objective and subjective apical cure rate. The primary outcomes were to determine the anatomic and symptomatic POP outcome, the secondary outcomes measures were to determine recurrence, reoperation rate, de novo POP and postoperative complications.

This is a prospective multicenter non-inferiority trial on 360 patients with vaginal bulge and apical +/- anterior and posterior prolapse scheduled for abdominal approach who underwent ASC or ALS. The surgeries were performed in two Gynaecologic Centres, between April 2013 and January 2019.
The condition of non-inferiority for ALS surgery related to ASC surgery (indicated as a prolapse recurrence variation rate not exceeding 10%) was analyzed. The number of patients needed to analyze the non-inferiority condition was 300, with ALS/ASC ratio equal 2. The cohort of 300 patients obtained after adjustment for age and BMI, were divided in 100 subjected at ALS and 200 patients subjected at ASC; in addition, to calculate p- value of non-inferiority, confidence interval (CI) method was applied. Categorical data were described by absolute and relative frequency, continuous data by mean and standard deviation. Chi square test and t-test were applied to analyze categorical and continuous data, respectively. The values of p<0.05 were considered significant. Statistical analysis was carried out by SPSS v.27 technology.

After 12 months follow-up the objective cure rate for apical defect was 92% for ALS and 94% for ASC (ALS recurrence 8% and ASC recurrence 6%; p-value of non-inferiority <0.01). The recurrence prolapse rate in the anterior compartment for ALS and ASC were 16.1% and 19.4% respectively (p= 0.652), and in the posterior compartment were 50% and 14.5% respectively (p= 0.019). Overall, subjective cure rate in terms of absence of vaginal bulge was >90% for both groups. Mesh complication rate were 0.7% and 1% for ALS and ASC. No patient had major postoperative complications in both groups, based on Clavien-Dindo scale.

The non-inferiority trial confirm that the new ALS strategy is not inferior to the gold standard ASC in terms of surgical treatment of apical POP.

A-MIS repair of apical prolapse with either ALS or ASC are safe, highly effective and durable.

Maher C., Feiner B., Baessler K., Surgery for women with apical vaginal prolapse, Cochrane Database of Systematic Reviews, 2016
Veit-Rubin N., Dubuisson J.B., Gayet-Ageron A., Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients, International Urogynecology Journal, 2017

Continence 2S2 (2022) 100240
DOI: 10.1016/j.cont.2022.100240