Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
NCT ID: NCT07119203
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
276 participants
INTERVENTIONAL
2025-09-12
2026-06-01
Brief Summary
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This is the first randomized controlled trial designed to compare RC with LC in the treatment of benign gallbladder disease. The trial aims to evaluate the safety and non-inferiority of RC relative to LC, providing important evidence to guide the progress and adoption of robotic surgery in clinical practice.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic cholecystectomy
Robotic multiport cholecystectomy
Robotic cholecystectomy
Robotic multiport cholecystectomy
Laparoscopic cholecystectomy
Conventional multiport laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Conventional multiport laparoscopic cholecystectomy
Interventions
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Robotic cholecystectomy
Robotic multiport cholecystectomy
Laparoscopic cholecystectomy
Conventional multiport laparoscopic cholecystectomy
Eligibility Criteria
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Inclusion Criteria
* Benign gallbladder disease: diagnosis of gallbladder polyps or symptomatic gallstones proven on imaging (ultrasound, computed tomography (CT) scan or magnetic resonance cholangiopancreatography (MRCP));
* Capacity to give informed consent.
Exclusion Criteria
* Evidence of acute cholecystitis;
* Known stones in the common bile duct (CBD);
* Suspicion of possible malignancy;
* Pregnancy;
* Diagnosis of liver cirrhosis (stage III or IV);
* Insufficient language skills to be able to perform the quality-of-life questionnaires.
18 Years
ALL
No
Sponsors
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Portsmouth Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Locations
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Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Jennifer Straatman
Role: primary
Cezanne Kooij
Role: backup
References
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Straatman J, Pucher PH, Knight BC, Carter NC, Glaysher MA, Mercer SJ, van Boxel GI. Systematic review: robot-assisted versus conventional laparoscopic multiport cholecystectomy. J Robot Surg. 2023 Oct;17(5):1967-1977. doi: 10.1007/s11701-023-01662-3. Epub 2023 Jul 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Official trial website
Other Identifiers
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333268
Identifier Type: -
Identifier Source: org_study_id