Actively Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Led by Portsmouth Hospitals NHS Trust · Updated on 2025-12-23
276
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, randomized controlled, parallel, non-inferiority trial. All adult patients with benign gallbladder disease with an indication for cholecystectomy will be assessed for eligibility and included after obtaining informed consent. A total of 276 patients will be randomized to undergo either robotic cholecystectomy (RC) or laparoscopic cholecystectomy (LC). The primary endpoint will be the incidence and severity of postoperative complications within 30 days after surgery. Secondary endpoints include perioperative outcomes, total health care utilization, health-related quality of life (HR-QoL) as assessed by patient-reported outcome measures, and cost-effectiveness. Follow-up assessments will be conducted at 7 and 30 days postoperatively. 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.
CONDITIONS
Official Title
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age equal or above 18 years
- Diagnosis of benign gallbladder disease such as gallbladder polyps or symptomatic gallstones confirmed by imaging (ultrasound, CT scan, or MRCP)
- Ability to give informed consent
You will not qualify if you...
- Minimally invasive surgery not possible according to the surgeon
- Evidence of acute cholecystitis
- Known stones in the common bile duct
- Suspicion of malignancy
- Pregnancy
- Diagnosis of liver cirrhosis stage III or IV
- Insufficient language skills to complete quality-of-life questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Actively Recruiting
Research Team
G
Gijsbert I. van Boxel
CONTACT
J
Jennifer Straatman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here