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.
12 December 2018 in Archives of Gynecology and Obstetrics
Background/Objectives: The objective is to assess if transvaginal infiltration with anaesthetic only is non-inferior compared to anaesthetic plus corticosteroid for the treatment of myofascial pelvic pain. Methods: A randomised, double-blind, parallel-group (1:1) clinical trial was set at the Department of Obstetrics and Gynaecology, Hospital Universitario “Príncipe de Asturias” from December 2017 to June 2023. Women presenting myofascial perineal pain ≥ 4 on the visual analogue scale (VAS) 2 months after delivery, with instrumental delivery or prolonged second stage (>3 h) or foetal weight > 4000 g, were randomised into two groups to receive levobupivacaine 5 mg/mL or levobupivacaine 5 mg/mL plus betamethasone 3 mg/mL. For each trigger point detected, a transvaginal infiltration was performed using the corresponding treatment. The patients were followed up to 6 months. The primary endpoint was a change in the VAS score from baseline at 6 months. Results: A total of 114 women were enrolled, with 57 randomly assigned to each group. The median (IQR) VAS 2 weeks after infiltration decreased by a similar magnitude: median (IQR) 2 (1–3) in the levobupivacaine group and 2 (1–4) in the levobupivacaine + betamethasone group (p-value = 0.33). The same trend was observed at 6 months: median (IQR) 1 (1–4) in the levobupivacaine group and 1 (1–2) in the levobupivacaine + betamethasone group (p-value = 0.85). Conclusions: This study provides evidence that the use of anaesthetic-only infiltration is non-inferior compared to anaesthetic plus corticosteroid for the treatment of myofascial perineal pain.
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.