Abstract / Summary
Importance Minimally invasive radical hysterectomy was introduced to reduce perioperative morbidity in early-stage cervical cancer, but concerns regarding oncologic safety have limited its use. High-quality prospective randomized data evaluating perioperative safety and recovery after robot-assisted radical hysterectomy remain limited. Objective To compare perioperative safety and health-related quality of life (HRQOL) after robot-assisted vs open radical hysterectomy. Design, Setting, and Participants The Robot-Assisted Approach to Cervical Cancer (RACC) trial, a multicenter, noninferiority, phase 3 randomized clinical trial, was conducted at tertiary centers in Europe. Female participants aged 18 years and older with cervical cancer (International Federation of Gynecology and Obstetrics [FIGO] 2018 stage IB [excluding IB3] or IIA1) were enrolled. Patients were randomized between 2019 and 2025. Interventions Robot-assisted laparoscopic radical hysterectomy. Main Outcomes and Measures Prespecified secondary outcomes included intraoperative complications (graded using standardized classification systems), postoperative complications within 30 days (Clavien-Dindo), and HRQOL at 1 month (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Cervical Cancer Module, and EuroQol 5-Dimension 3-Level questionnaire). These prespecified secondary analyses were exploratory and were not powered for confirmatory inference. Results Of 900 randomized patients (robotic surgery, median [IQR] age, 46 [39-53] years; open surgery, median [IQR] age, 45 [37-54] years), 809 (90%) were included in the intraoperative safety analysis, 798 (89%) in the postoperative safety analysis, and 723 (80%) in the 1-month HRQOL analysis. Intraoperative complications occurred in 24 of 419 patients (5.7%) in the robot-assisted group vs 39 of 390 patients (10.0%) in the open surgery group (risk difference, −4.3 percentage points; 95% CI, −8.0 to −0.6 percentage points); most were minor, whereas major complications were infrequent and similar. Postoperative complications within 30 days were similar (33.4% vs 34.8%; risk difference, −1.4 percentage points; 95% CI, −7.9 to 5.2 percentage points), including readmission and reoperation. At 1 month, robot-assisted surgery was associated with small differences in selected domains, including physical functioning (+5 points; 95% CI, 3-8 points), role functioning (+8 points; 95% CI, 4-13 points), and lower pain (+5 points; 95% CI, 2-9 points), whereas most domains did not meet thresholds for clinically important differences. Conclusions and Relevance Results of this secondary analysis of the RACC randomized clinical trial show that robot-assisted radical hysterectomy was associated with fewer intraoperative complications, primarily reflecting lower-grade events, with similar postoperative morbidity compared with open surgery. Differences in early HRQOL were small, and overall findings indicate no improvement in clinically consequential postoperative outcomes or recovery. Trial Registration ClinicalTrials.gov Identifier: NCT03719547