TY - JOUR
T1 - Robot-assisted surgery for the management of apical prolapse
T2 - a bi-centre prospective cohort study
AU - van Zanten, F.
AU - Schraffordt Koops, S. E.
AU - O'Sullivan, O. E.
AU - Lenters, E.
AU - Broeders, I. A.M.J.
AU - O'Reilly, B. A.
N1 - Funding Information:
This study was performed in accordance with the ethical regulations of the Clinical Research Ethics Committee (CREC, University College Cork, Ireland) and the National Central Committee on Research Involving Human Subjects (CCMO, the Netherlands). No funding was received to conduct this study. Statistical analysis was performed using SPSS 22.0 (IBM Corp., Armonk, NY, USA). Data were presented as mean ± standard deviation (SD) and median and interquartile range (IQR) for normally and non-normally distributed continuous values, respectively. In the case of sPOPQ values with only four stages, data were presented as means ± SDs. Numbers and percentages were used for nominal and categorical values. Independent-
Publisher Copyright:
© 2019 Royal College of Obstetricians and Gynaecologists
PY - 2019/7
Y1 - 2019/7
N2 - Objective: Robot-assisted surgery is a recognised treatment for pelvic-organ prolapse. Many of the surgical subgroup outcomes for apical prolapse are reported together, leading to a paucity of homogenous data. Design: Prospective observational cohort study (NCT01598467, clinicaltrials.gov) assessing outcomes for homogeneous subgroups of robot-assisted apical prolapse surgery. Setting: Two European tertiary referral hospitals. Population: Consecutive patients undergoing robot-assisted sacrocolpopexy (RASC) and supracervical hysterectomy with sacrocervicopexy (RSHS). Methods: Anatomical cure (simplified Pelvic Organ Prolapse Quantification, sPOPQ, stage 1), subjective cure (symptoms of bulge), and quality of life (Pelvic Floor Impact Questionnaire, PFIQ-7). Main outcome measures: Primary outcome: anatomical and subjective cure. Secondary outcomes: surgical safety and intraoperative variables. Results: A total of 305 patients were included (RASC n = 188; RSHS n = 117). Twelve months follow-up was available for 144 (RASC 76.6%) and 109 (RSHS 93.2%) women. Anatomical success of the apical compartment occurred for 91% (RASC) and in 99% (RSHS) of the women. In all compartments, the success percentages were 67 and 65%, respectively. Most recurrences were in the anterior compartment [15.7% RASC (symptomatic 12.1%); 22.9% RSHS (symptomatic 4.8%)]. Symptoms of bulge improved from 97.4 to 17.4% (P < 0.0005). PFIQ-7 scores improved from 76.7 ± 62.3 to 13.5 ± 31.1 (P < 0.0005). The duration of surgery increased significantly for RSHS [183.1 ± 38.2 versus 145.3 ± 29.8 (P < 0.0005)]. Intraoperative complications and conversion rates were low (RASC, 5.3 and 4.3%; RSHS, 0.0 and 0.0%). Four severe postoperative complications occurred after RASC (2.1%) and one occurred after RSHS (1.6%). Conclusions: This is the largest reported prospective cohort study on robot-assisted apical prolapse surgery. Both procedures are safe, with durable results. Tweetable abstract: European bi-centre trial concludes that robot-assisted surgery is a viable approach to managing apical prolapse.
AB - Objective: Robot-assisted surgery is a recognised treatment for pelvic-organ prolapse. Many of the surgical subgroup outcomes for apical prolapse are reported together, leading to a paucity of homogenous data. Design: Prospective observational cohort study (NCT01598467, clinicaltrials.gov) assessing outcomes for homogeneous subgroups of robot-assisted apical prolapse surgery. Setting: Two European tertiary referral hospitals. Population: Consecutive patients undergoing robot-assisted sacrocolpopexy (RASC) and supracervical hysterectomy with sacrocervicopexy (RSHS). Methods: Anatomical cure (simplified Pelvic Organ Prolapse Quantification, sPOPQ, stage 1), subjective cure (symptoms of bulge), and quality of life (Pelvic Floor Impact Questionnaire, PFIQ-7). Main outcome measures: Primary outcome: anatomical and subjective cure. Secondary outcomes: surgical safety and intraoperative variables. Results: A total of 305 patients were included (RASC n = 188; RSHS n = 117). Twelve months follow-up was available for 144 (RASC 76.6%) and 109 (RSHS 93.2%) women. Anatomical success of the apical compartment occurred for 91% (RASC) and in 99% (RSHS) of the women. In all compartments, the success percentages were 67 and 65%, respectively. Most recurrences were in the anterior compartment [15.7% RASC (symptomatic 12.1%); 22.9% RSHS (symptomatic 4.8%)]. Symptoms of bulge improved from 97.4 to 17.4% (P < 0.0005). PFIQ-7 scores improved from 76.7 ± 62.3 to 13.5 ± 31.1 (P < 0.0005). The duration of surgery increased significantly for RSHS [183.1 ± 38.2 versus 145.3 ± 29.8 (P < 0.0005)]. Intraoperative complications and conversion rates were low (RASC, 5.3 and 4.3%; RSHS, 0.0 and 0.0%). Four severe postoperative complications occurred after RASC (2.1%) and one occurred after RSHS (1.6%). Conclusions: This is the largest reported prospective cohort study on robot-assisted apical prolapse surgery. Both procedures are safe, with durable results. Tweetable abstract: European bi-centre trial concludes that robot-assisted surgery is a viable approach to managing apical prolapse.
KW - Pelvic organ prolapse
KW - robot-assisted
KW - sacral colpopexy
KW - sacrocervicopexy
KW - sacrocolpopexy
KW - n/a OA procedure
UR - https://www.scopus.com/pages/publications/85065431267
U2 - 10.1111/1471-0528.15696
DO - 10.1111/1471-0528.15696
M3 - Article
C2 - 30924606
AN - SCOPUS:85065431267
SN - 1470-0328
VL - 126
SP - 1065
EP - 1073
JO - BJOG
JF - BJOG
IS - 8
ER -