Robot-Assisted Hysterectomy Yields Fewer Intraoperative Complications in Cervical Cancer

Robot-assisted radical hysterectomy was associated with fewer intraoperative complications, but similar postoperative morbidity compared with open surgery in patients with early-stage cervical cancer, according to a prespecified secondary analysis of the phase 3 RACC trial (NCT03719547) published in JAMA Surgery.¹ The trial’s primary end point of recurrence-free survival remains under follow-up and will be reported separately.

What were the perioperative safety results from the RACC trial?

Among 809 patients in the intraoperative safety analysis, complications occurred in 24 of 419 patients (5.7%) in the robot-assisted arm vs 39 of 390 patients (10.0%) in the open surgery arm (risk difference, −4.3 percentage points; 95% CI, −8.0 to −0.6; risk ratio, 0.57; 95% CI, 0.35-0.93). Most events were minor; major intraoperative complications occurred in 2 patients (0.5%) and 4 patients (1.0%), respectively. There were no grade IV or V intraoperative events.

Postoperative complications within 30 days were similar in the 798 patients evaluated, occurring in 135 of 404 patients (33.4%) in the robot-assisted arm and 137 of 394 patients (34.8%) in the open surgery arm (risk difference, −1.4 percentage points; 95% CI, −7.9 to 5.2). Major postoperative complications occurred in 5.9% vs 6.9% of patients.

How did robot-assisted surgery affect recovery and quality of life?

The median length of hospital stay was 3 days (IQR, 2-4) following robot-assisted surgery vs 5 days (IQR, 4-6) with open surgery. Readmission and reoperation rates were similar between groups. The median estimated blood loss was 75 mL with the robotic approach vs 250 mL with open surgery, and the median operative time was longer with the robotic approach (237 minutes [IQR, 188-287] vs 209 [IQR, 175-243] minutes).

At 1 month, health-related quality of life (HRQOL) analyses of 723 patients showed small differences favoring robot-assisted surgery in physical functioning (mean difference, +5 points; 95% CI, 3-8), role functioning (+8 points; 95% CI, 4-13), and pain (+5 points; 95% CI, 2-9). These values were calculated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale. Most other domains did not meet thresholds for clinically important differences. Findings on sexual functioning were based on few respondents and pointed in opposite directions across domains.

Using the cervical cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24), most domains were similar and had small between-group differences at 1 month. Differences were noted for sexual/vaginal functioning and sexual enjoyment. Sexual/vaginal functioning was favorable in the open surgery arm (mean difference, –12; 95% CI, –20 to –3). Sexual enjoyment was favorable in the robot-assisted surgery arm (mean difference, +20; 95% CI, 7-33). Investigators noted that these findings should be interpreted “cautiously” because the number of respondents was limited; this reflects the low proportion of sexually active patients at the 1-month assessment.

“In clinical practice, perioperative advantages alone are unlikely to justify selection of robot-assisted surgery but may provide important context when discussing surgical trade-offs with patients,” wrote lead study author Sahar Salehi, MD, PhD, surgeon and director of Ovarian Cancer Surgery in the Department of Pelvic Cancer at Karolinska University Hospital, with coauthors.¹ “Oncologic outcome remains the primary determinant of surgical approach in early-stage cervical cancer. Therefore, the overall role of robot-assisted radical hysterectomy should ultimately be interpreted in conjunction with the forthcoming primary oncologic results of the RACC trial.”

How was the RACC trial designed?

RACC is an international, multicenter, open-label, noninferiority trial coordinated by Karolinska University Hospital in Stockholm, Sweden. Investigators randomly assigned 900 patients 1:1 to robot-assisted laparoscopic or open radical hysterectomy between 2019 and 2025.¹ Eligible patients were females 18 years or older with histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB (excluding IB3) or IIA1 cervical cancer. Patients also had an ECOG performance status of 0 to 2 and were deemed suitable for radical hysterectomy.

Intraoperative events were graded with the Classification of Intraoperative Complications (CLASSIC) and Kaafarani classifications, and postoperative events within 30 days were graded with the Clavien-Dindo system. The perioperative analyses were exploratory and not powered for confirmatory inference.

References

Salehi S, Norberg Hardie A, Smolders RGV, et al. Perioperative outcomes and recovery after robot-assisted vs open radical hysterectomy: a secondary analysis of the RACC randomized clinical trial. JAMA Surg. Published online October 7, 2026. doi:10.1001/jamasurg.2026.4625