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.
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.
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;
Parallel
Robotic cholecystectomy
Procedure/SurgeryRobotic multiport cholecystectomy
Laparoscopic cholecystectomy
Procedure/SurgeryConventional multiport laparoscopic cholecystectomy
Incidence (%) of postoperative complications within 30 days after surgery
The incidence (%) of postoperative complications occurring within 30 days after surgery in patients with benign gallbladder disease. The outcome compares the total number of complications between patients treated with robotic cholecystectomy (RC) and those treated with laparoscopic cholecystectomy (LC).
Severity of postoperative complications within 30 days after surgery
Complication severity will be graded using the Clavien-Dindo classification: 1. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. 2. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. 3. Requiring surgical, endoscopic or radiological intervention i. intervention not under general anaesthesia ii. intervention under general anaesthesia 4. Life-threatening complication (including central nervous system complications), requiring management in an Intensive Care Unit (ICU). 5. Death of a patient
Frequency (%) of postoperative complications within 30 days postoperatively
The frequency (%) of individual postoperative complications occurring within 30 days following surgery in patients undergoing cholecystectomy.
Comprehensive Complication Index (CCI) score within 30 days after surgery
The Comprehensive Complication Index (CCI) is a validated score based on the Clavien-Dindo classification system that quantifies all postoperative complications occurring within 30 days after surgery. The score ranges from 0 (no complications) to 100 (death), reflecting the cumulative burden of morbidity per patient.
Duration of the procedure (minutes)
Two time intervals will be recorded to assess procedure duration and robotic set-up times: Total time spent in the operating theatre, measured as the time from patient arrival (hh:mm) to exit (hh:mm). Actual surgical time, measured as the time from skin incision ("knife to skin") to skin closure (hh:mm). Times will be recorded in minutes.
Peri-operative blood loss (millilitres)
Peri-operative blood loss will be measured quantitatively in millilitres. Additionally, the number of tonsil swabs used during the procedure will be recorded as a qualitative indicator of blood loss.
Intra-abdominal pressure (mmHg) during surgery
Intra-abdominal pressure will be continuously measured in millimeters of mercury (mmHg) during insufflation throughout the surgical procedure.
Incidence (%) of gallbladder perforation during surgery
The percentage (%) of surgical procedures in which perforation of the gallbladder occurs intraoperatively.
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