Preliminary Results of a Multicenter Randomized Clinical Trial for Laparoscopic Repair of Pelvic Organ Prolapse: Sacropexy vs. Laparoscopic Lateral Suspension.

Abstract

Background: Laparoscopic sacropexy (SCL) is the gold standard technique for the correction of apical pelvic organ prolapse (POP). However, other easier laparoscopic techniques, such as laparoscopic lateral suspension (LLS), have become popular. Methods: We conducted a multicenter randomized study of patients undergoing laparoscopic repair of apical and anterior prolapse. Patients were randomized into two groups: LLS vs. SCL. A non-inferiority study was proposed, in which the null hypothesis was that the difference in the proportion of therapeutic failures among women who undergo LLS compared to SCL is ≥15%. It was necessary to include 182 participants to detect a risk difference of 15% after one year with a statistical power of 0.80. Results: We recruited 176 women, of whom 106 patients underwent surgery with a follow-up between 1 and 12 months. There were no differences in basal characteristics. Regarding physical examination, there were no differences at stages III-IV in the POP-Q or the symptom scales in both groups. Concerning the post-surgical results, there were no failures detected in the physical examination in any group. There were no differences in the points of the POP-Q, the symptom scales, or the body image scale. We only found significant differences in the operative time, which was shorter for the LLS. Conclusions: Although these are preliminary results, since the sample includes 106 patients and the follow-up time is a limited period at the moment, we did not find any post-surgical differences between the two techniques. However, it will be necessary to complete the trial to draw relevant conclusions.