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.
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.
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).
Parallel
Robotic-assisted radical cholecystectomy
Procedure/SurgeryProcedure will be performed robotic-assisted
Open radical cholecystectomy
Procedure/SurgeryProcedure will be open
Time to functional recovery
As defined as: 1. has adequate pain control with oral analgesics only (NRS\<5) 2. is independently mobile at the preoperative level 3. is able to maintain sufficient oral caloric intake (minimum of 50% required calories) 4. has no need for intravenous fluid administration 5. has no clinical signs of infection or infection treated with peroral antibiotics only
Number of retrieved lymph nodes
As reported by pathologists
Length of hospital stay
Time from operation until hospital discharge (days)
Post-operative complications
Classified according to Clavien-Dindo
Quality of life of patients
Using quality of life formulaire EORTC QLQ-C30
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Karolinska University Hospital
Lead sponsor
University Hospital, Linkoeping
Collaborator
Sahlgrenska University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
