Clinical trial NCT06246448: Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)
Official title: Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - an International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gall Bladder Cancer
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: Sahlgrenska University Hospital
name: Rigshospitalet, Denmark
First posted: 2024-02-07
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Time to functional recovery
timeFrame: Days from operation
Secondary outcomes:
measure: Number of retrieved lymph nodes
timeFrame: Within 6 weeks after surgery
measure: Length of hospital stay
timeFrame: Days
measure: Post-operative complications
timeFrame: Within 90 days from surgery
measure: Quality of life of patients
timeFrame: 1 year
measure: Total cost
timeFrame: 1 year
measure: Abdominal wall complaints
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm
Study officials:
affiliation: Region Stockholm, Stockholm, Sweden
name: Christian Sturesson, PhD
role: PRINCIPAL_INVESTIGATOR
References: