About this trial
The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting.
The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.
Eligibility criteria
Qualifiers
Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference.
Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.
Disqualifiers
Previous extensive surgery in the upper abdomen (for example open liver surgery)
Pregnancy
Intraoperative findings of dissemination (patient is then excluded after randomization)
Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization).
Trial design
Treatments tested in this trial
- Robotic-assisted radical cholecystectomy
- Open radical cholecystectomy
Treatment groups
Locations
1Sponsors and collaborators
Karolinska University Hospital
Lead sponsor
University Hospital, Linkoeping
Collaborator
Sahlgrenska University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator