Authors
Sahar Salehi, Anna Norberg Hardie, Ramon G V Smolders, Luigi Pedone Anchora, Antonio Gil-Moreno, Enrico Vizza, Octavio Arencibia Sanchez, Evelyn Lundin, Jordi Ponce, Anna Fagotti, Hemming Johansson, Yvonne Brandberg, Katrine Fuglsang, Pernilla Dahm-Kähler, Dorry Boll, Ligita Paskeviciute Frøding, Lena Wijk, Karin Stålberg, Francesco Legge, Radovan Pilka, Algirdas Markauskas, Barbara Geppert, Thaïs Baert, Ulrika Ottander, Sandrina Lambrechts, Petra L M Zusterzeel, Juan Gilabert Estellés, C G Gerestein, Kolbrun Palsdottir, Henrik Falconer
Published in
JAMA surgery. Oct 07, 2026. Epub Oct 07, 2026.
Abstract
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.
To compare perioperative safety and health-related quality of life (HRQOL) after robot-assisted vs open radical hysterectomy.
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.
Robot-assisted laparoscopic radical hysterectomy.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03719547.
PMID:
42842268
Bibliographic data and abstract were imported from PubMed on 08 Oct 2026.
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