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

Not Applicable

Recruiting

• Conditions: Gall Bladder Cancer

• Registration Number: NCT06246448
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study Start: 2024-01-23
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to functional recovery	Days from operation	As defined as: 1. has adequate pain control with oral analgesics only (NRS\<5) 2. is independently mobile at the preoperative level 3. is able to maintain sufficient oral caloric intake (minimum of 50% required calories) 4. has no need for intravenous fluid administration 5. has no clinical signs of infection or infection treated with peroral antibiotics only

Secondary Outcome Measures

Name	Time	Method
Quality of life of patients	1 year	Using quality of life formulaire EORTC QLQ-C30
Abdominal wall complaints	1 year	Using the ventral hernia pain questionnaire
Post-operative complications	Within 90 days from surgery	Classified according to Clavien-Dindo
Length of hospital stay	Days	Time from operation until hospital discharge (days)
Number of retrieved lymph nodes	Within 6 weeks after surgery	As reported by pathologists
Total cost	1 year	Direct and indirect cost measured in euros

Trial Locations

Locations (1)

Region Stockholm; 🇸🇪 Stockholm, Sweden