At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Robotic cholecystectomy (procedure), Laparoscopic cholecystectomy (procedure)
- How long the study runs
- Study runs about 23 months (dates as stated)
- About the drug or intervention
- Robotic cholecystectomy — procedure: Robotic multiport cholecystectomy · Laparoscopic cholecystectomy — procedure: Conventional multiport laparoscopic cholecystectomy
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 276
- Started
- 2025-09-12
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for cholecystectomy, robotic
- • NA - 276 participants
- • This is a single-center, randomized controlled, parallel, non-inferiority trial
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cholecystectomy, robotic
Where?
- • Portsmouth - Queen Alexandra Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age equal or above 18 years;
- ✓Capacity to give agreement to take part.
Who cannot take part
- ✗Minimally invasive procedure is not deemed possible by the operating surgeon;
- ✗Evidence of acute cholecystitis;
- ✗Known stones in the common bile duct (CBD);
- ✗Suspicion of possible cancer;
- ✗Pregnancy;
See the full criteria
Where Is This Study? (1 UK site)
Queen Alexandra Hospital
Portsmouth PO6 3LY, United Kingdom
How to Get in Touch
Gijsbert I. van Boxel
Sponsor contactCONTACT
Jennifer Straatman
Sponsor contactCONTACT