An interventional study of Robotic-assisted radical cholecystectomy and Open radical cholecystectomy in Gall Bladder Cancer, sponsored by Karolinska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment
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.
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.
301 studies on the registry are indexed under Gallbladder Neoplasms; 65 are open to participants now.
This study's planned enrollment of 94 is above the median of 56 across 222 interventional studies indexed under Gallbladder Neoplasms.
Browse Gallbladder Neoplasms studies →Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Procedure: Robotic-assisted radical cholecystectomy
Procedure: Open radical cholecystectomy
Procedure will be performed robotic-assisted
Procedure will be open
Time to functional recovery
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
Time frame: Days from operation
Number of retrieved lymph nodes
As reported by pathologists
Time frame: Within 6 weeks after surgery
Length of hospital stay
Time from operation until hospital discharge (days)
Time frame: Days
Post-operative complications
Classified according to Clavien-Dindo
Time frame: Within 90 days from surgery
Quality of life of patients
Using quality of life formulaire EORTC QLQ-C30
Time frame: 1 year
Total cost
Direct and indirect cost measured in euros
Time frame: 1 year
Abdominal wall complaints
Using the ventral hernia pain questionnaire
Time frame: 1 year
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Oct 2026, 33 months after the start.
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