Robotic versus laparoscopic gallbladder removal for benign gallbladder disease

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease: A Randomized Controlled, Open, Parallel, Non-inferiority, Single-center Trial (STaRLING Trial)

This trial will test whether robotic gallbladder removal is as safe as standard laparoscopic surgery for adults who need their gallbladder removed for benign disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Portsmouth Hospitals NHS Trust (Government)
• Locations: 1 site (Portsmouth)
• Trial ID: NCT07119203 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, parallel non-inferiority trial enrolling 276 adults with benign gallbladder disease who require cholecystectomy. Participants are randomly assigned to either robotic cholecystectomy or conventional laparoscopic cholecystectomy and followed up at 7 and 30 days after surgery. The primary outcome is the incidence and severity of postoperative complications within 30 days; secondary outcomes include perioperative measures, total health care utilization, patient-reported health-related quality of life, and cost-effectiveness. The trial is designed to determine whether robotic surgery provides comparable safety and resource use to standard laparoscopy.

Who should consider this trial

Good fit: Adults (age ≥18) with benign gallbladder disease such as symptomatic gallstones or gallbladder polyps who are eligible for minimally invasive cholecystectomy and can give informed consent.

Not a fit: Patients with acute cholecystitis, known common bile duct stones, suspected malignancy, advanced liver cirrhosis (stage III/IV), pregnancy, insufficient language skills for questionnaires, or those deemed unsuitable for minimally invasive surgery are not likely to benefit or be eligible.

Why it matters

Potential benefit: If successful, robotic cholecystectomy could offer comparable safety with potential benefits in recovery, patient experience, or overall cost-effectiveness compared with standard laparoscopy.

How similar studies have performed: Robotic cholecystectomy has been reported in observational series but this is the first randomized controlled trial directly comparing robotic and laparoscopic cholecystectomy for benign gallbladder disease.

Eligibility criteria

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.

Where this trial is running

Portsmouth

• Queen Alexandra Hospital — Portsmouth, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Gijsbert I. van Boxel

Conditions Cholecystectomy, Robotic; Cholecystectomy, Laparoscopic; Cholecystectomy; Gallstones; Benign Gallbladder Disease; Robotic cholecystectomy; Laparoscopic cholecystectomy; Benign gallbladder disease