Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07119203

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy in Benign Gallbladder Disease A Randomized Controlled, Open, Parallel, Non-inferiority, Single-center Trial

Led by Portsmouth Hospitals NHS Trust · Updated on 2025-12-23

276

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 provide informed consent
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

Queen Alexandra Hospital

Portsmouth, United Kingdom, PO6 3LY

Actively Recruiting

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Research Team

G

Gijsbert I. van Boxel

J

Jennifer Straatman

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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Published Research Related To This Trial

Surgical Techniques: Robotic versus conventional Laparoscopic cholecystectomy IN benign Gallbladder disease: a randomized controlled, open, parallel, non-inferiority, single-center trial (STaRLING trial).

Jennifer Straatman, Cezanne D Kooij, Stuart J Mercer...

https://pubmed.ncbi.nlm.nih.gov/41731509