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

Study acronym: STaRLING
StatusRecruiting
PhaseNot applicable
Started2025-09-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 14 months later Jun 1, 2026 → Aug 1, 2027
See other at-risk trials from Portsmouth Hospitals NHS Trust

Amendment history

2026-09-16
critical
Primary completion pushed: 2026-06-01 → 2027-08-01
Completion pushed: 2026-06-01 → 2027-08-01
2025-12-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03-01→2026-06-01
Completion date2026-03-01→2026-06-01
Start dateestimated 2025-08-01→confirmed 2025-09-12
Study sites1 entry, revised
PortsmouthQueen HospitalsAlexandra University NHS TrustHospital
2025-08-05
minor
Original filing
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.
Trial Details
NCT Number NCT07119203
Lead Sponsor Portsmouth Hospitals NHS Trust
Conditions Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic, Cholecystectomy, Gallstones, Benign Gallbladder Disease
Enrollment 276 participants
Start Date 2025-09-12
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-15