International multicenter randomized-controlled trial comparing morbidity and quality of life between laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer

Background: Comparative international data on postoperative morbidity and quality of life (QoL) between laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer remain limited. Methods: This international randomized controlled trial (RCT) aimed to compare complications and QoL outcomes between patients who underwent LADG and TLDG. In total, 888 patients from participating countries with histologically confirmed gastric adenocarcinoma (clinical stage I gastric cancer) were screened, and 884 were randomized to undergo LADG or TLDG between 2018 and 2021. The primary endpoint was 30-day postoperative morbidity. Secondary endpoints included QoL assessments using the EORTC QLQ-C30 and QLQ-STO22 questionnaires. Complications and QoL were assessed at baseline, immediately postoperatively, and at 30 days and 3, 6, and 12 months. Results: This study included 429 (mean age, 58.76 years) and 415 patients (mean age, 58.24 years) in the TLDG and LADG groups, respectively, with no significant differences in age, sex, or body mass index. Early complication rates were 8.9% and 11.1% in the TLDG and LADG groups, respectively (P = .33). Postoperative ileus incidence was 0.7% and 3.6% in the TLDG and LADG groups, respectively (P = .007). QoL scores differed between groups for constipation, fatigue, and anxiety at 3 months and for constipation and financial difficulty at 6 months; no differences were observed at 12 months. Conclusion: The findings revealed no significant difference in overall postoperative complication rates between the LADG and TLDG groups. The TLDG group had a lower ileus incidence and transient QoL improvements in four EORTC STO22 items during the early postoperative period.