RecruitingNot ApplicableNCT06246448

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

Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial

Sponsor

Karolinska University Hospital

Enrollment

94 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

Gall Bladder Cancer

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria5

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)