手術手技：良性胆道疾患におけるロボット支援腹腔鏡下胆嚢摘出術 vs. 従来の腹腔鏡下胆嚢摘出術：無作為化比較開腹並行非劣性単一施設試験（STaRLING試験）

Robotic surgery is increasingly being adopted for gallbladder removal, despite the absence of randomized trials comparing its safety and patient outcomes to the current gold standard, laparoscopic cholecystectomy (LC). Existing literature reviews have found several case series showing no significant differences in postoperative complications or recovery between robotic cholecystectomy (RC) and LC. This trial aims to evaluate whether RC is non-inferior to conventional LC.

This is a prospective single-center, randomized controlled, parallel, non-inferiority trial. All adult patients with benign gallbladder disease with an indication for cholecystectomy will be assessed for eligibility and included after obtaining informed consent. A total of 276 patients will be randomized to undergo either RC or LC. The primary endpoint will be the incidence and severity of postoperative complications within 30 days after surgery. Secondary endpoints include perioperative outcomes, total health care utilization, health-related quality of life (HR-QoL) as assessed by patient-reported outcome measures, and cost-effectiveness. Follow-up assessments will be conducted at 7 and 30 days postoperatively.

This is the first randomized controlled trial designed to compare RC with LC in the treatment of benign gallbladder disease. The trial aims to evaluate the safety and non-inferiority of RC relative to LC, providing important evidence to guide the progress and adoption of robotic surgery in clinical practice.

This trial was registered on 14 July 2025 at ClinicalTrials.gov with the identifier NCT07119203, https://clinicaltrials.gov/study/NCT07119203.