Region Stockholm
Stockholm, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT06246448
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Robotic-assisted radical cholecystectomy
ProcedureProcedure will be performed robotic-assisted
Open radical cholecystectomy
ProcedureProcedure will be open
Primary outcomes
-
Time to functional recovery
Time frame: 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 outcomes
-
Number of retrieved lymph nodes
Time frame: Within 6 weeks after surgery
As reported by pathologists
-
Length of hospital stay
Time frame: Days
Time from operation until hospital discharge (days)
-
Post-operative complications
Time frame: Within 90 days from surgery
Classified according to Clavien-Dindo
-
Quality of life of patients
Time frame: 1 year
Using quality of life formulaire EORTC QLQ-C30
-
Total cost
Time frame: 1 year
Direct and indirect cost measured in euros
-
Abdominal wall complaints
Time frame: 1 year
Using the ventral hernia pain questionnaire
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Karolinska University Hospital
Other
Collaborators
- Rigshospitalet, Denmark
- Sahlgrenska University Hospital
- University Hospital, Linkoeping
Registry information
Official study title
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial
Acronym: ROBOCOP
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Feb 7, 2024
- Registry last updated
- Sep 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
DESTINY-PANTUMOUR04
NCT07124000
Adenocarcinoma, Adenocarcinoma (NOS)
Birmingham, Alabama, United States
View Trial Details
Recruiting
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
NCT05000294
Adenocarcinoma, Adnexal Diseases
Gainesville, Florida, United States
View Trial Details
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
NCT07059884
Adnexal Diseases, Anal Cancer
Dublin, California, United States
View Trial Details
Recruiting
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)
NCT06101277
Adenocarcinoma, Appendiceal Cancer
Sacramento, California, United States
View Trial Details