Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)

Summary

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

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)

Conditions2

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