Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse.
Aged
Analgesics
/ therapeutic use
Blood Loss, Surgical
Cicatrix
/ etiology
Female
Humans
Intraoperative Complications
/ etiology
Laparoscopy
/ adverse effects
Length of Stay
/ statistics & numerical data
Ligaments
/ surgery
Middle Aged
Operative Time
Pain, Postoperative
/ etiology
Pelvic Organ Prolapse
/ surgery
Quality of Life
Robotic Surgical Procedures
/ adverse effects
Sacrum
Severity of Illness Index
Surveys and Questionnaires
Treatment Outcome
Vagina
/ surgery
hysterectomy
laparoscopic single-site (LESS)
multi-port robotic (MPR)
pelvic organ prolapse (POP)
robotic laparoendoscopic single-site (R-LESS)
sacrocolpopexy
Journal
American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
16
06
2019
revised:
24
09
2019
accepted:
30
09
2019
pubmed:
8
10
2019
medline:
13
5
2020
entrez:
8
10
2019
Statut:
ppublish
Résumé
Sacrocolpopexy is a commonly performed procedure for repair of apical compartment prolapse. A Y-shaped mesh is attached to the prolapsed cervix or vagina and suspended to the anterior longitudinal ligament of the sacrum. In addition to conventional laparoscopic and multi-port robotic routes, the robotic laparoendoscopic single-site approach has emerged as a viable, feasible, and widely applicable minimally invasive approach to sacrocolpopexy. To compare robotic laparoendoscopic single-site with multi-port robotic sacrocolpopexy for women with either utero-vaginal or vaginal apical prolapse. In this single-center randomized controlled trial, 70 women at Pelvic Organ Prolapse Quantitative stages 2-4 were assigned randomly to undergo sacrocolpopexy by robotic laparoendoscopic single-site or multi-port robotic approaches from August 2017 to November 2018. Of 35 women randomized to each group, 32 underwent sacrocolpopexy. Operating time was the primary outcome of the trial. Secondary outcomes included intraoperative bleeding, length of hospitalization, pain during the first postoperative 24 hours (according to a 0-10 visual analogue scale), need for analgesics, and intraoperative and postoperative adverse events. At 6 weeks and 6 months after surgery, patients underwent a physical examination according to Pelvic Organ Prolapse Quantitative measurements, to assess the anatomical success of the surgery. The Pelvic Floor Distress Inventory-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual-12 questionnaires were administered prior to surgery and at 6-month follow-up. The Patient Scar Assessment Questionnaire and the Activity Assessment Scale were administered at 6 weeks and 6 months after the surgery. Exclusion criteria included contraindication to general anesthesia, a history of prior sacrocolpopexy, suspicious adnexal masses, suspicious thickened endometrium, and morbid obesity (body mass index of 40 kg/m The mean age of the patients was 58.4 years. More than half of the patients (54%) had stage III prolapse. Mean total operative times were 181.3 ± 32.6 and 157.5 ± 42 minutes for robotic laparoendoscopic single-site and multi-port robotic sacrocolpopexy, respectively; the difference was 23.8 minutes (95% confidence interval, 4.2-43.4, P = .018). The mean differences in duration between the procedures were as follows: 29.8 minutes, 95% confidence interval, 9.2-50.4, P = .005 for anesthesia time; 33.1 minutes, 95% confidence interval, 16.5-49.7, P < .0001 for console time; 8.6 minutes, 95% confidence interval, 1.1-16.3, P = .025 for supracervical hysterectomy time; 8.3 minutes, 95% confidence interval, 1.8-14.8, P = 0.03 for mesh suturing and fixation to the promontory; and 4.7 minutes, 95% confidence interval, 1.5-7.7, P = .004 for peritoneum suturing. Statistically significant differences were not observed between the groups in regard to estimated blood loss, intraoperative complications, and demand for analgesics during hospital stay. Quality-of-life parameters were similar. Patients' assessments of their scars were more favorable in the robotic laparoendoscopic single-site group. For sacrocolpopexy, the operative time was longer for the robotic laparoendoscopic single-site than for the multi-port robotic approach. Both approaches are feasible, and short-term outcomes, quality-of-life parameters, and anatomic repair are comparable. Our results are generalizable only to the specific robotic platforms used in the study.
Sections du résumé
BACKGROUND
Sacrocolpopexy is a commonly performed procedure for repair of apical compartment prolapse. A Y-shaped mesh is attached to the prolapsed cervix or vagina and suspended to the anterior longitudinal ligament of the sacrum. In addition to conventional laparoscopic and multi-port robotic routes, the robotic laparoendoscopic single-site approach has emerged as a viable, feasible, and widely applicable minimally invasive approach to sacrocolpopexy.
OBJECTIVE
To compare robotic laparoendoscopic single-site with multi-port robotic sacrocolpopexy for women with either utero-vaginal or vaginal apical prolapse.
MATERIALS AND METHODS
In this single-center randomized controlled trial, 70 women at Pelvic Organ Prolapse Quantitative stages 2-4 were assigned randomly to undergo sacrocolpopexy by robotic laparoendoscopic single-site or multi-port robotic approaches from August 2017 to November 2018. Of 35 women randomized to each group, 32 underwent sacrocolpopexy. Operating time was the primary outcome of the trial. Secondary outcomes included intraoperative bleeding, length of hospitalization, pain during the first postoperative 24 hours (according to a 0-10 visual analogue scale), need for analgesics, and intraoperative and postoperative adverse events. At 6 weeks and 6 months after surgery, patients underwent a physical examination according to Pelvic Organ Prolapse Quantitative measurements, to assess the anatomical success of the surgery. The Pelvic Floor Distress Inventory-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual-12 questionnaires were administered prior to surgery and at 6-month follow-up. The Patient Scar Assessment Questionnaire and the Activity Assessment Scale were administered at 6 weeks and 6 months after the surgery. Exclusion criteria included contraindication to general anesthesia, a history of prior sacrocolpopexy, suspicious adnexal masses, suspicious thickened endometrium, and morbid obesity (body mass index of 40 kg/m
RESULTS
The mean age of the patients was 58.4 years. More than half of the patients (54%) had stage III prolapse. Mean total operative times were 181.3 ± 32.6 and 157.5 ± 42 minutes for robotic laparoendoscopic single-site and multi-port robotic sacrocolpopexy, respectively; the difference was 23.8 minutes (95% confidence interval, 4.2-43.4, P = .018). The mean differences in duration between the procedures were as follows: 29.8 minutes, 95% confidence interval, 9.2-50.4, P = .005 for anesthesia time; 33.1 minutes, 95% confidence interval, 16.5-49.7, P < .0001 for console time; 8.6 minutes, 95% confidence interval, 1.1-16.3, P = .025 for supracervical hysterectomy time; 8.3 minutes, 95% confidence interval, 1.8-14.8, P = 0.03 for mesh suturing and fixation to the promontory; and 4.7 minutes, 95% confidence interval, 1.5-7.7, P = .004 for peritoneum suturing. Statistically significant differences were not observed between the groups in regard to estimated blood loss, intraoperative complications, and demand for analgesics during hospital stay. Quality-of-life parameters were similar. Patients' assessments of their scars were more favorable in the robotic laparoendoscopic single-site group.
CONCLUSION
For sacrocolpopexy, the operative time was longer for the robotic laparoendoscopic single-site than for the multi-port robotic approach. Both approaches are feasible, and short-term outcomes, quality-of-life parameters, and anatomic repair are comparable. Our results are generalizable only to the specific robotic platforms used in the study.
Identifiants
pubmed: 31589864
pii: S0002-9378(19)31214-1
doi: 10.1016/j.ajog.2019.09.048
pii:
doi:
Substances chimiques
Analgesics
0
Banques de données
ClinicalTrials.gov
['NCT03034499']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
358.e1-358.e11Informations de copyright
Copyright © 2019. Published by Elsevier Inc.