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

Karolinska University Hospital94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gall Bladder Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts