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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

NCT03491878

Gallbladder Cancer Surgery

UNKNOWN NA

Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study

NCT00562900

Cholecystolithiasis

COMPLETED PHASE4

Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves

NCT03059745

Cholecystitis Cholelithiasis

COMPLETED

Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

NCT04551820

Cholecystectomy

COMPLETED

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease

NCT07119203

Cholecystectomy, Robotic Cholecystectomy, Laparoscopic Cholecystectomy +2 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gall Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic-assisted radical cholecystectomy

Group Type EXPERIMENTAL

Robotic-assisted radical cholecystectomy

Intervention Type PROCEDURE

Procedure will be performed robotic-assisted

Open radical cholecystectomy

Group Type ACTIVE_COMPARATOR

Open radical cholecystectomy

Intervention Type PROCEDURE

Procedure will be open

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic-assisted radical cholecystectomy

Procedure will be performed robotic-assisted

Intervention Type PROCEDURE

Open radical cholecystectomy

Procedure will be open

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No