NEW YORK (Reuters Health) – Robotic gastrectomy failed to reduce intra-abdominal infectious complications compared with standard laparoscopic gastrectomy in a randomized clinical trial of 236 patients with gastric cancer.
However, the high-tech procedure did appear to lower the overall incidence of postoperative complications slightly, decreasing the observed need for pain medications during recovery and expediting the return of peristalsis.
“Reducing surgical stress and relieving postoperative pain will facilitate postoperative recovery in gastric-cancer patients,” Dr. Toshiyasu Ojima of Wakayama Medical University in Japan, told Reuters Health by email. “We hypothesized that rapid recovery of gastrointestinal peristalsis and milder surgical stress after robotic gastrectomy may result in postoperative pain relief.”
To test whether robotic gastrectomy could lower the incidence of intra-abdominal infectious complications such as postoperative pancreatic fistulas and abscesses, Dr. Ojima and colleagues randomly assigned 241 patients to undergo either the robot-assisted procedure or traditional laparoscopic surgery. Five patients were excluded before undergoing treatment.
The primary endpoint of postoperative intra-abdominal infectious complications of Clavien-Dindo grade II or higher occurred in 6% of the robotic group versus 8.4% of the non-robotic group (P=0.47) in the modified intention-to-treat (mITT) analysis.
In the per-protocol (PP) analysis, which excluded six patients whose procedure required conversion to open gastrectomy, or from the robotic to the traditional laparoscopic approach, the rates were 6.2% and 8.5%, respectively (P=0.50).
These results remained consistent when the complications were stratified by severity or category of complication, the researchers report in JAMA Surgery.
The researchers conclude that, “contrary to expectation, there was no reduction of intra-abdominal infectious complications with robotic gastrectomy compared with laparoscopic gastrectomy.”
The robotic group did fare somewhat better with respect to the overall incidence of postoperative complications of grade II or higher, a secondary endpoint (mITT: 8.5% vs. 19.3%; PP: 8.8% vs. 19.7%; P=0.02). This held true for clinically serious complications of grade IIIa or higher in the PP analysis (PP: 5.3% vs. 16.2%; P=0.01).
The median time to flatus was two days in both groups, although the time was significantly in favor of the robotic approach. Patients in the latter group received a median of one dose of analgesic versus two in the other group (P=0.001).
There was no difference in time to ambulation or length of stay.
“The results of the secondary end points showed good short-term surgical outcomes in both the laparoscopic gastrectomy and robotic gastrectomy groups,” Dr. Ojima and colleagues write.
There was no significant difference in intraoperative blood loss, but the robotic procedure took almost an hour longer and was associated with significantly more combined resections (14.5% vs. 5.9%).
“The high rates of combined resection of the spleen in the robotic gastrectomy group (6.0% vs. 0.8%) may be associated with prolonged operation time,” the researchers say.
For the surgeons themselves, said Dr. Ojima, “Robotic surgery has ergonomic advantages over conventional laparoscopy, including seven degrees of motion in the robotic instruments assisted by the wrist-like instruments tips, less fatigue, tremor filtering, motion scaling, and three-dimensional vision.”
However, it is still “an expensive operation,” he added. “In Japan, the price of one robot (da Vinci Xi) is 300 million JPY ($2.7 million USD), and the running cost per robotic surgery is 300,000 JPY ($2,700 USD).”
The mean age among patients was 71 years and 64% were men. The two groups were balanced regarding institution and planned gastrectomy type (distal gastrectomy and total or proximal gastrectomy) using the minimization method with a random component.
Patients with pathologic stage-II or -III gastric cancers were also treated for one year with adjuvant chemotherapy with S-1, an oral fluoropyrimidine.
Further comparative study between robotic gastrectomy and traditional laparoscopic gastrectomy would be desirable, according to Dr. Ojima, with a focus on other postoperative complications, including pulmonary, cardiovascular, liver, urinary and thrombosis events.
The researchers report no funding source or conflicts of interest.
SOURCE: https://bit.ly/39h7bOt JAMA Surgery, online September 1, 2021.
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