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

Karolinska University Hospital

Status: Enrolling

Conditions: Gall Bladder Cancer

Treatments: Procedure: Robotic-assisted radical cholecystectomy; Procedure: Open radical cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06246448

CS001

Details and patient eligibility

About

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.

Full description

Robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. With a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. With an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Robotic-assisted radical cholecystectomy

Experimental group

Treatment:

Procedure: Robotic-assisted radical cholecystectomy

Open radical cholecystectomy

Active Comparator group

Treatment:

Procedure: Open radical cholecystectomy