Comparing Robotic and Conventional Laparoscopic Surgery for Benign Gallbladder Disease A Randomized Trial
Led by Portsmouth Hospitals NHS Trust · Updated on 2025-12-23
276
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical techniques for treating benign gallbladder disease, including gallbladder polyps and symptomatic gallstones, in adults. This randomized controlled trial compares robotic cholecystectomy RC with conventional laparoscopic cholecystectomy LC to assess if RC is not worse than LC in terms of safety. The study is designed to provide important evidence to guide the use of robotic surgery in clinical practice.
A total of 276 adult patients will be randomly assigned to one of two groups one undergoing robotic multiport cholecystectomy and the other conventional multiport laparoscopic cholecystectomy. Both procedures are performed as surgery to remove the gallbladder. The trial will measure postoperative complications and other surgery-related outcomes to compare the two methods.
Participants will be followed up at 7 and 30 days after surgery to assess the number and severity of complications, recovery quality, health-related quality of life using patient questionnaires, and healthcare costs. Researchers will collect data on procedure duration, blood loss, bile duct assessment, pain medication use, hospital discharge timing, readmissions, and quality of recovery. The total study participation lasts through the 30-day postoperative period.
CONDITIONS
Brief Title
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Research Team
G
Gijsbert I. van Boxel
J
Jennifer Straatman
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Diagnosis of benign gallbladder disease such as gallbladder polyps or symptomatic gallstones confirmed by imaging (ultrasound, CT scan, or MRCP)
Ability to provide informed consent
You will not qualify if you...
Minimally invasive procedure is not deemed possible by the operating surgeon
Evidence of acute cholecystitis
Presence of 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 complete quality-of-life questionnaires adequately
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo either robotic or conventional laparoscopic cholecystectomy and receive immediate post-operative care.
1 surgical visit and recovery period
Post-operative Follow-up
Duration - 30 days
Participants are monitored for complications and recovery for 30 days after surgery.
Visits at hospital discharge, 7 days postoperatively, and 30 days postoperatively
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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