Intraoperative Adverse Events, Technical Performance, and Surgical Outcomes in Laparoscopic Radical Surgery for Gastric Cancer: A Pooled Analysis From 2 Randomized Trials.

Abstract

To verify an intraoperative adverse event (iAE) classification (ClassIntra grade) to evaluate quality control and to predict the prognostic performance of laparoscopic radical surgery for gastric cancer. Surgical quality control is a key factor in the evaluation of surgical treatment for tumors. And, there is no recognized iAE classification for gastric cancer. We performed a retrospective post hoc analysis of previously collected data from the FUGES-001 study (NCT02327481) and a subset of the CLASS-01 study (NCT01609309). Patients were classified into the iAE and non-iAE groups. And iAE was further classified into 5 subgrades according to the ClassIntra grade (with I-V severity categories). Technical performance was evaluated using the Objective Structured Assessment of Technical Skills tool and the Generic Error Rating Tool. Overall, 528 gastric cancer patients were included in this study, with 105 patients (19.9%) in the iAE group and 423 (80.1%) in the non-iAE group. The survival curve showed that the overall, disease-specific, and recurrence-free survival of the non-iAE group were significantly better than those of the iAE group ( P =0.001). The prognosis of patients with ClassIntra grade ≥II was significantly worse than that of patients with ClassIntra grade ≤I. A higher ClassIntra grade, lower Objective Structured Assessment of Technical Skills score, and total gastrectomy were independent risk factors for severe postoperative complications. There was a significant increase in bleeding (grade IV) and injury with splenic hilar lymph node dissection during total gastrectomy. The ClassIntra grade is an effective prognostic and surgical quality control index for laparoscopic radical surgery for gastric cancer; therefore, it could be included in routine hospital care and surgical quality control.