Clinical trial · Interventional
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gall Bladder Cancer | Gallbladder Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open radical cholecystectomy | Procedure | — | UNRESOLVED |
| Robotic-assisted radical cholecystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic-assisted radical cholecystectomy
- interventionNames
- Procedure: Robotic-assisted radical cholecystectomy
- type
- ACTIVE_COMPARATOR
- label
- Open radical cholecystectomy
- interventionNames
- Procedure: Open radical cholecystectomy
Primary outcomes (1)
- measure
- Time to functional recovery
- timeFrame
- Days from operation
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDWallgren 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. PMID 40621784