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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

PROCEDURE

Robotic-assisted radical cholecystectomy

Procedure will be performed robotic-assisted

PROCEDURE

Open radical cholecystectomy

Procedure will be open

Locations (1)

Region Stockholm
Stockholm, Sweden