Robotic versus conventional laparoscopic cholecystectomy in benign gallbladder disease
The STARLING trial is a randomised clinical trial comparing robotic multi-port cholecystectomy with conventional laparoscopic cholecystectomy. We hypothesize that robotic multi-port cholecystectomy is, at least, as safe as conventional laparoscopic cholecystectomy with regards to morbidity and complications within 30 days after surgery. Robotic surgery for cholecystectomy is increasingly being applied. Previous observational studies showed promising results, but the studies are small, limited by selection bias and most studies include patients that were operated during the learning curve of robotic surgery. A prospective randomized trial, in a hospital setting where the learning curve has been completed will allow for true comparison of robotic multiport cholecystectomy to conventional laparoscopic cholecystectomy. Conventional laparoscopic cholecystectomy, or multi-port keyhole surgery or the gallbladder, is the current gold standard for treatment of benign gallbladder disease, and this will be the control arm for the trial. All adult (>18 years) patients, presenting with benign gallbladder disease can be included in the study. For specific in- and exclusion criteria, please see the appropriate section. This study is estimated to take 12 months to complete. We expect to need about 8 months for inclusions, an additional month is needed to collect all follow-up assessments. With over 500 elective cholecystectomies performed annually in our Trust, we expect this to be ample time to obtain all 276 inclusions. The final three months are allocated to perform the analyses and draft manuscripts. Laparoscopic and robotic cholecystectomy are already commonly applied in PHU. Given our literature review and experience with both procedures within the Trust, in combination with the short time span of the trial, an interim analysis is not deemed contributory. Upon finalizing the trial inclusions, we aim to complete analyses and report within 4 months. The research team is aw
1. Age equal or above 18 years 2. Diagnosis of benign gallbladder disease (gallstones or gallbladder polyp) as proven on imaging (ultrasound scan and/or magnetic resonance cholangiopancreatography) 3. Capacity to give informed consent
1. Minimally invasive procedure is not deemed possible by the operating surgeon 2. Evidence of acute cholecystitis, requiring acute surgery 3. Known stones in the common bile duct at time of surgery 4. Suspicion of possible malignancy 5. Pregnancy 6. Diagnosis of liver cirrhosis, stage III or IV 7. Insufficient language skills to be able to perform the quality-of-life questionnaires