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Trial Title:
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)
NCT ID:
NCT06246448
Condition:
Gall Bladder Cancer
Conditions: Official terms:
Gallbladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic-assisted radical cholecystectomy
Description:
Procedure will be performed robotic-assisted
Arm group label:
Robotic-assisted radical cholecystectomy
Intervention type:
Procedure
Intervention name:
Open radical cholecystectomy
Description:
Procedure will be open
Arm group label:
Open radical cholecystectomy
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Region Stockholm
Address:
City:
Stockholm
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Christian Sturesson, PhD
Email:
christian.sturesson@regionstockholm.se
Start date:
January 23, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
University Hospital, Linkoeping
Agency class:
Other
Collaborator:
Agency:
Sahlgrenska University Hospital, Sweden
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246448
