Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic cholecystectomy, Laparoscopic cholecystectomy.
- Who it may be relevant to
- Registry conditions: Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic, Cholecystectomy, Gallstones. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease: A Randomized Controlled, Open, Parallel, Non-inferiority, Single-center Trial (STaRLING Trial)
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.
Interventions
- Procedure Robotic cholecystectomy
Robotic multiport cholecystectomy - Procedure Laparoscopic cholecystectomy
Conventional multiport laparoscopic cholecystectomy
Primary outcome measures
- Incidence (%) of postoperative complications within 30 days after surgery [Time frame: From day of surgery up to 30 days postoperatively]
- Severity of postoperative complications within 30 days after surgery [Time frame: From day of surgery up to 30 days postoperatively]
- Frequency (%) of postoperative complications within 30 days postoperatively [Time frame: From day of surgery up to 30 days postoperatively]
- Comprehensive Complication Index (CCI) score within 30 days after surgery [Time frame: From day of surgery up to 30 days postoperatively]
Secondary outcome measures (12)
- Duration of the procedure (minutes) [Time frame: Intraoperatively]
- Peri-operative blood loss (millilitres) [Time frame: Intraoperatively]
- Intra-abdominal pressure (mmHg) during surgery [Time frame: Intraoperatively]
- Incidence (%) of gallbladder perforation during surgery [Time frame: Intraoperatively]
- Incidence (%) of intraoperative complications [Time frame: Intraoperatively]
- Technical difficulty of the procedure graded according to Nassar classification [Time frame: Intraoperatively]
- Assessment of liver parenchyma during surgery [Time frame: Intraoperatively]
- Proportion of procedures in which common bile duct (CBD) assessment was performed [Time frame: Intraoperatively]
- Proportion (%) of patients who underwent common bile duct (CBD) exploration [Time frame: Intraoperatively]
- Use of peri-operative antibiotics [Time frame: Intraoperatively]
- Incidence (%) and number of drains placed during surgery [Time frame: Intraoperatively]
- Surgical perceived effort measured by Surgical Task Load Index (SURG TLX) [Time frame: Intraoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Queen Alexandra Hospital — Portsmouth
Publications
- Straatman J, Pucher PH, Knight BC, Carter NC, Glaysher MA, Mercer SJ, van Boxel GI. Systematic review: robot-assisted versus conventional laparoscopic multiport cholecystectomy. J Robot Surg. 2023 Oct;17(5):1967-1977. doi: 10.1007/s11701-023-01662-3. Epub 2023 Jul 13. PMID 37439902
- Straatman J, Kooij CD, Mercer SJ, Pucher PH, Glaysher MA, Jenkins N, Tucker V, Carter NC, van Boxel GI. Surgical Techniques: Robotic versus conventional Laparoscopic cholecystectomy IN benign Gallbladder disease: a randomized controlled, open, parallel, non-inferiority, single-center trial (STaRLING trial). Trials. 2026 Feb 24;27(1):254. doi: 10.1186/s13063-026-09458-0. PMID 41731509
Identifiers
NCT: NCT07119203 · 333268