RecruitingNot ApplicableNCT07119203

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN 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)


Sponsor

Portsmouth Hospitals NHS Trust

Enrollment

276 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Laparoscopic cholecystectomy and a procedure called Robotic cholecystectomy for people with benign gallbladder disease, cholecystectomy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERobotic cholecystectomy

Robotic multiport cholecystectomy

PROCEDURELaparoscopic cholecystectomy

Conventional multiport laparoscopic cholecystectomy


Locations(1)

Queen Alexandra Hospital

Portsmouth, United Kingdom

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NCT07119203


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