RecruitingNot Applicable

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease

United Kingdom276 participantsStarted 2025-09-12

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence (%) of postoperative complications within 30 days after surgery

Timeframe: From day of surgery up to 30 days postoperatively

Severity of postoperative complications within 30 days after surgery

Timeframe: From day of surgery up to 30 days postoperatively

Frequency (%) of postoperative complications within 30 days postoperatively

Timeframe: From day of surgery up to 30 days postoperatively

Comprehensive Complication Index (CCI) score within 30 days after surgery

Timeframe: From day of surgery up to 30 days postoperatively

Trial details

NCT IDNCT07119203

SponsorPortsmouth Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Gijsbert I. van Boxel

+44 023 9228 6000 g.vanboxel@nhs.net

View on ClinicalTrials.gov More Cholecystectomy, Robotic trials