Robot-assisted surgery for early-stage cervical cancer was associated with fewer complications during the operation itself than open surgery, but the difference mainly involved less serious events. This did not lead to fewer complications after surgery or to better overall recovery. This is shown by the first publication from the international randomised RACC study. The results are published in JAMA Surgery.
In early-stage cervical cancer, radical hysterectomy is an established treatment. The operation can be performed either through open surgery or robot-assisted keyhole surgery. Until now, there has been limited data from large randomised studies on differences in complications and recovery between the methods.
In the RACC study, 900 patients with early-stage cervical cancer were randomised to robot-assisted or open radical hysterectomy at hospitals across Europe. The study is coordinated from Karolinska University Hospital and led by Henrik Falconer , adjunct senior lecturer at the Department of Women's and Children's Health at Karolinska Institutet and principal investigator for the RACC study.
Complications during surgery were recorded in 5.7 per cent of patients in the robotic surgery group compared with 10.0 per cent in the open surgery group. The difference was mainly driven by less serious complications. Serious complications were uncommon and similar between the groups.
However, the lower rate of complications during robotic surgery did not lead to fewer complications after surgery. Within 30 days, 33.4 per cent of patients in the robotic surgery group and 34.8 per cent in the open surgery group had experienced a complication. Serious complications, readmissions and reoperations were also similar between the groups.
"We saw fewer complications during the robotic operation itself, but they were mainly less serious. The important point is that this difference did not lead to fewer complications after surgery," says Sahar Salehi , associate professor at the same Department and gynaecological cancer surgeon at Karolinska University Hospital, who is responsible for the current publication.
One month after surgery, there were small differences in some aspects of the patients' quality of life, including physical function and pain. For most measures, however, no clinically meaningful differences were seen, and overall early recovery was similar between the groups.
"Overall, the results show that the expected benefits of robot-assisted surgery were limited. The fewer complications during surgery did not translate into better clinically meaningful outcomes after surgery or better overall recovery," says Sahar Salehi.
The current article is the first publication from the RACC study and reports predefined secondary outcome measures. The study's primary outcome measure is recurrence-free survival, and patients are still being followed for this outcome. The oncological results will be reported separately. The results of the current study should therefore not be used to assess the oncological safety of robot-assisted surgery.
Publication
Sahar Salehi, MD, PhD; Anna Norberg Hardie, MD; Ramon G. V. Smolders, MD, PhD. et al.