Work

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

Year: 2025

Type: article

Abstract: Background: Laparoscopic sacropexy (SCL) is the gold standard technique for the correction of apical pelvic organs prolapse (POP). However, other easier laparoscopic techniques such as laparoscopic lateral suspension (LLS) have become popular. Methods: A multicentre randomized study of patients undergoing laparoscopic repair of severe apical and anterior prolapse. Patients were randomized into 2 groups: LLS vs SCL. A non-inferiority study is proposed in which the null hypothesis is that the difference in the proportion of therapeutic failures among women who undergo LLS compared to SCL is ≥15%. It will be necessary to include 182 participants to detect a risk difference of 15% (at one year with a statistical power of 0.80). Results: we have recruited 176 women, and 106 patients have been operated with a follow-up between 1 and 12 months. There were not differences in basal characteristics. Regarding physical examination, there were no differences in stages III-IV in the POP-Q neither the symptom scales in both groups. Concerning post-surgical results there were no failures in the physical examination in any group. There were no differences in the points of the POP-Q neither in the symptom scales or Body image scale. We only found significant differences in the operative time, being shorter for the LLS. Conclusion: Although these are preliminary results, since the sample is 100 patients and the follow-up time is short, at the moment, we didn’t find post-surgical differences between the 2 techniques. However, it is necessary to complete the trial to draw relevant conclusions.

Source: Journal of Clinical Medicine

DOI: 10.3390/jcm14062069