TOPLINE

In patients with early-stage cervical cancer, robot-assisted radical hysterectomy was associated with fewer intraoperative complications than open surgery, but the difference was driven mostly by minor events, according to a secondary analysis of a phase 3 trial. Complications within 30 days of surgery, readmissions, and reoperations were similar between the two approaches, and at 1 month, differences in health-related quality of life (HRQOL) were small and limited to selected domains.

METHODOLOGY

• Minimally invasive approaches, including robot-assisted radical hysterectomy, were introduced to lower the risk for surgical complications in patients with early-stage cervical cancer. However, later randomized evidence showed worse oncologic outcomes with minimally invasive approaches than with open surgery, prompting guidelines to favor open procedures. Perioperative safety and patient recovery remain key considerations in counseling and surgical decision-making; however, data on perioperative safety and quality of life after robotic surgery remain limited.
• To address this, researchers conducted a prespecified secondary analysis of a noninferiority, phase 3 randomized trial that compared robot-assisted laparoscopic radical hysterectomy with open radical hysterectomy in women with early-stage cervical cancer (International Federation of Gynecology and Obstetrics 2018 stage IB [excluding IB3] or IIA1).
• A total of 900 patients were randomly assigned to undergo robot-assisted surgery (n = 455; median age, 46 years) or open surgery (n = 445; median age, 45 years); the intention-to-treat population comprised 842 patients.
• Researchers compared prespecified secondary outcomes between the groups. These outcomes were intraoperative complications (graded with the Classification of Intraoperative Complications and Kaafarani systems and categorized as lower-grade or higher-grade events), postoperative complications within 30 days (graded with the Clavien-Dindo system), and HRQOL at 1 month (measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module, and the EuroQol 5-Dimension 3-Level questionnaire). 
• Overall, 809 patients (robot-assisted group, 419; open-surgery group, 390) were included in the intraoperative safety analysis, 798 (robot-assisted group, 404; open-surgery group, 394) in the postoperative safety analysis, and 723 (robot-assisted group, 365; open-surgery group, 358) in the 1-month quality-of-life analysis.

TAKEAWAY

• Intraoperative complications were less frequent in the robot-assisted group than in the open-surgery group, occurring in 24 of 419 patients (5.7%) vs 39 of 390 patients (10.0%); the risk difference was -4.3 percentage points and the risk ratio (RR) was 0.57.
• Major intraoperative complications were rare, with low-grade events predominating, and their rates were similar between the groups (robot-assisted surgery, n = 2 [0.5%]; open surgery, n = 4 [1.0%]).
• Postoperative complication rates within 30 days were similar between the groups (135 of 404 patients [33.4%] in the robot-assisted group vs 137 of 394 patients [34.8%] in the open-surgery group; risk difference, -1.4 percentage points; RR, 0.96), as were readmission and reoperation rates. Hospital stay was shorter with robotic surgery (median, 3 days vs 5 days), but operative time was longer (237 minutes vs 209 minutes) and blood loss was lower (75 mL vs 250 mL).
• At 1 month, robot-assisted surgery was associated with small gains in physical functioning (mean difference, +5 points) and role functioning (mean difference, +8 points) and lower pain scores (mean difference, +5 points) compared with open surgery.

IN PRACTICE

"These findings from prespecified secondary analyses should be interpreted as exploratory and indicate that although robot-assisted surgery reduced intraoperative complications, these differences do not translate into improvements in clinically consequential postoperative outcomes or recovery," the authors wrote. ″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."

SOURCE

The study, led by Sahar Salehi, MD, PhD, Karolinska University Hospital and Karolinska Institutet in Stockholm, Sweden, was published online in JAMA Surgery.

LIMITATIONS

Blinding of surgeons and patients was not possible, and surgeon skill and center experience may have influenced results. The analyses were secondary and exploratory. They were not powered for confirmatory testing and were not adjusted for multiple comparisons, so clinically meaningful differences could not be excluded. No intraoperative grading system has been validated in gynecologic oncology, so events may have been underreported or misclassified.

DISCLOSURES

The study was supported by grants from the Swedish Cancer Society, KWF Dutch Cancer Society, Region Stockholm, Nordic Cancer Union, and Intuitive Foundation. Some authors reported receiving personal fees, research support, or having other ties with various sources, including support unrelated to this work. Full author disclosures are reported in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.