Overview

This is a 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 robotic cholecystectomy (RC) or laparoscopic cholecystectomy (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.

Eligibility

Inclusion Criteria:

• Age equal or above 18 years;
• Benign gallbladder disease: diagnosis of gallbladder polyps or symptomatic gallstones proven on imaging (ultrasound, computed tomography (CT) scan or magnetic resonance cholangiopancreatography (MRCP));
• Capacity to give informed consent.

Exclusion Criteria:

• Minimally invasive procedure is not deemed possible by the operating surgeon;
• Evidence of acute cholecystitis;
• Known stones in the common bile duct (CBD);
• Suspicion of possible malignancy;
• Pregnancy;
• Diagnosis of liver cirrhosis (stage III or IV);
• Insufficient language skills to be able to perform the quality-of-life questionnaires.