Ester Illiano1, Pasquale Ditonno2, Konstantinos Giannitsas3, Gaetano De Rienzo2, Vittorio Bini4, Elisabetta Costantini5. 1. Andrology and Urogynecology Clinic, Santa Maria Terni, Terni Hospital, Department of Surgical and Biomedical Science, University of Perugia, Italy. Electronic address: ester.illiano@inwind.it. 2. Urology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 3. Department of Urology, Patras University Hospital, Patras University, Patras, Greece. 4. Internal Medicine, Endocrine and Metabolic Science Section, Department of Medicine, University of Perugia, Italy. 5. Andrology and Urogynecology Clinic, Santa Maria Terni, Terni Hospital, Department of Surgical and Biomedical Science, University of Perugia, Italy.
Abstract
OBJECTIVE: To compare robot assisted to laparoscopic sacrocolpopexy, in terms of efficacy, in the treatment of high-stage pelvic organ prolapse. METHODS: This was a noninferiority prospective randomized trial conducted in a tertiary Urology unit, comparing robot assisted and laparoscopic sacrocolpopexy in patients with symptomatic prolapse stage III and IV, according to the Pelvic Organ Prolapse quantification. All participants provided written informed consent at enrolment. The primary outcome was prolapse objective cure rate. Secondary outcomes included prevalence of urinary, anorectal and sexual symptoms, UDI-6, IIQ7 and FSFI scores, and maximum flow rate. Operative times, intraoperative blood loss, length of hospital stay, postsurgery pain, patient satisfaction as well as surgical and mesh complications were assessed. The Mann-Whitney and Wilcoxon tests for unpaired and paired data, respectively, were used to compare ordinal and nonnormally distributed continuous variables. Categorical data were analyzed by the McNemar, chi-square or Fisher exact test. Two-tailed P <.05 was considered significant. RESULTS:One hundred patients were randomized. At a mean follow-up of 24.06 months the cure rate for the apical compartment was 100% with both approaches. There were no significant between-group differences in any of the secondary outcomes with the only exception of C/D point values, where results were significantly better in the robot-assisted group. Overall surgical procedure time was longer in the robot-assisted group. The main limitation of our study is the single-centre design and the inclusion of docking time in robotic-procedure surgical time calculations. CONCLUSION:Robot-assisted sacrocolpopexy provides outcomes comparable to those of laparoscopic with 100% anatomic correction of the apical compartment.
RCT Entities:
OBJECTIVE: To compare robot assisted to laparoscopic sacrocolpopexy, in terms of efficacy, in the treatment of high-stage pelvic organ prolapse. METHODS: This was a noninferiority prospective randomized trial conducted in a tertiary Urology unit, comparing robot assisted and laparoscopic sacrocolpopexy in patients with symptomatic prolapse stage III and IV, according to the Pelvic Organ Prolapse quantification. All participants provided written informed consent at enrolment. The primary outcome was prolapse objective cure rate. Secondary outcomes included prevalence of urinary, anorectal and sexual symptoms, UDI-6, IIQ7 and FSFI scores, and maximum flow rate. Operative times, intraoperative blood loss, length of hospital stay, postsurgery pain, patient satisfaction as well as surgical and mesh complications were assessed. The Mann-Whitney and Wilcoxon tests for unpaired and paired data, respectively, were used to compare ordinal and nonnormally distributed continuous variables. Categorical data were analyzed by the McNemar, chi-square or Fisher exact test. Two-tailed P <.05 was considered significant. RESULTS: One hundred patients were randomized. At a mean follow-up of 24.06 months the cure rate for the apical compartment was 100% with both approaches. There were no significant between-group differences in any of the secondary outcomes with the only exception of C/D point values, where results were significantly better in the robot-assisted group. Overall surgical procedure time was longer in the robot-assisted group. The main limitation of our study is the single-centre design and the inclusion of docking time in robotic-procedure surgical time calculations. CONCLUSION: Robot-assisted sacrocolpopexy provides outcomes comparable to those of laparoscopic with 100% anatomic correction of the apical compartment.