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

Last updated: March 4, 2025
Sponsor: Karolinska University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Cancer

Treatment

Open radical cholecystectomy

Robotic-assisted radical cholecystectomy

Clinical Study ID

NCT06246448
CS001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladdercancer after cholecystectomy with an indication of radical cholecystectomy, withoutthe need for resection of extrahepatic bile ducts, as decided at a multidisciplinaryteam conference.

  • Patient sufficiently fit to undergo radical cholecystectomy according to surgeon andanaesthesiologist.

Exclusion

Exclusion Criteria:

  • Previous extensive surgery in the upper abdomen (for example open liver surgery)

  • Pregnancy

  • Intraoperative findings of dissemination (patient is then excluded afterrandomization)

  • 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 thenexcluded after randomization)

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Open radical cholecystectomy
Phase:
Study Start date:
January 23, 2024
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Region Stockholm

    Stockholm,
    Sweden

    Active - Recruiting

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