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| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted radical cholecystectomy | Experimental |
| |
| Open radical cholecystectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted radical cholecystectomy | Procedure | Procedure will be performed robotic-assisted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Days from operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrieved lymph nodes | As reported by pathologists | Within 6 weeks after surgery |
| Length of hospital stay | Time from operation until hospital discharge (days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Sturesson, PhD | Contact | 0046812380000 | christian.sturesson@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Christian Sturesson, PhD | Region Stockholm, Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Stockholm | Recruiting | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40621784 | Derived | Wallgren H, Gilg S, Ansorge C, Sparrelid E, Sturesson C. Initial experience with robotic-assisted resection for suspected or confirmed gallbladder cancer - comparison with open technique in a single centre retrospective observational cohort study. Scand J Gastroenterol. 2025 Jul 7:1-6. doi: 10.1080/00365521.2025.2525902. Online ahead of print. |
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| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Open radical cholecystectomy | Procedure | Procedure will be open |
|
| Days |
| Post-operative complications | Classified according to Clavien-Dindo | Within 90 days from surgery |
| Quality of life of patients | Using quality of life formulaire EORTC QLQ-C30 | 1 year |
| Total cost | Direct and indirect cost measured in euros | 1 year |
| Abdominal wall complaints | Using the ventral hernia pain questionnaire | 1 year |
| D001660 |
| Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |