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

Plain Language Summary

Simplified for easier understanding

This trial (called ROBOCOP) is comparing robotic surgery versus traditional open surgery for patients with suspected or confirmed gallbladder cancer that requires a more extensive procedure called radical cholecystectomy — removal of the gallbladder along with nearby liver tissue and lymph nodes. The goal is to see if robotic surgery is equally safe and effective while being less invasive. **You may be eligible if...** - You have suspected or confirmed gallbladder cancer (stage T1b or higher) discovered after a prior cholecystectomy (gallbladder removal) - A multidisciplinary team has determined that you need a radical (more extensive) re-operation - The surgery does not require removal of the bile duct - You are healthy enough to undergo surgery as determined by your surgeon and anesthesiologist **You may NOT be eligible if...** - You have had major prior abdominal surgery (such as open liver surgery) that would make the procedure very difficult - You are pregnant - Cancer is found to have spread inside the abdomen during surgery (found after randomization) - The bile duct needs to be removed during surgery (found after randomization) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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