STARLING trial
Research type
Research Study
Full title
Surgical Techniques: Robotic versus conventional Laparoscopic cholecystectomy IN benign Gallbladder disease.
IRAS ID
333268
Contact name
G.I. van Boxel
Contact email
Sponsor organisation
Portsmouth Hospitals University NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Robotic surgery is increasingly being adopted for gallbladder removal, whereas no randomized trial has been performed to assess patient safety and outcomes in comparison to the current gold standard: laparoscopic gallbladder removal. The STARLING trial is a prospective randomized clinical trial, in which adult patients with benign gallbladder disease (e.g. gallstones), will be randomized between robotic multiport gallbladder removal and conventional laparoscopic multiport gallbladder removal. The primary outcome will be complications within 30 days postoperatively, as a measure of patient safety. Secondary outcomes include intra-operative outcomes, patient recovery (including return to work), patient reported outcomes measures (PROMs) for quality of life and recovery and cost-effectiveness. Peri-operative care and work-up will be similar in both groups.
When adopting a novel technique, this technique should be as safe as the current standard. Robotic cholecystectomy should be non-inferior in complication rate to conventional laparoscopic cholecystectomy. The sample size for non-inferiority is based on previous literature; taking into account a two-sided 90% confidence interval a total of 276 patients are to be randomized.
All operations will be performed by surgeons with experience in both conventional laparoscopic, and robotic multiport cholecystectomy. Eligible surgeons have to have performed at least 32 robotic cholecystectomies. We expect to complete recruitment and primary analysis within 2 years.REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0297
Date of REC Opinion
14 Apr 2025
REC opinion
Favourable Opinion