Robotic versus laparoscopic gallbladder removal for benign gallbladder disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, parallel non-inferiority trial enrolling 276 adults with benign gallbladder disease who require cholecystectomy. Participants are randomly assigned to either robotic cholecystectomy or conventional laparoscopic cholecystectomy and followed up at 7 and 30 days after surgery. The primary outcome is the incidence and severity of postoperative complications within 30 days; secondary outcomes include perioperative measures, total health care utilization, patient-reported health-related quality of life, and cost-effectiveness. The trial is designed to determine whether robotic surgery provides comparable safety and resource use to standard laparoscopy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age equal or above 18 years;
* 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:

* 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 malignancy;
* Pregnancy;
* Diagnosis of liver cirrhosis (stage III or IV);
* Insufficient language skills to be able to perform the quality-of-life questionnaires.

Where it's running

• Queen Alexandra Hospital
  Portsmouth, United Kingdom Recruiting

Study contacts

• Study coordinator: Gijsbert I. van Boxel
• Email: g.vanboxel@nhs.net
• Phone: +44 023 9228 6000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Opiranserin plus acetaminophen vs NSAIDs plus acetaminophen after minimally invasive gallbladder removal

  This trial tests whether opiranserin with acetaminophen works as well as NSAIDs with acetaminophen for pain after a minimally invasive cholecystectomy.

  Recruiting Gangnam Severance Hospital · Seoul and 1 other locations · NCT07620665

• Improvised retrieval bag vs direct gallbladder extraction in laparoscopic cholecystectomy

  This trial tests whether using an improvised retrieval bag to remove the gallbladder during laparoscopic cholecystectomy is as safe and effective as removing it directly without a bag in adults with gallbladder stones.

  Recruiting Rawal Institute of Health Sciences Islamabad · Islamabad, Federal · NCT07823803

• Recto-Intercostal and External Oblique Intercostal Blocks for Pain after Laparoscopic Gallbladder Removal

  This trial tests whether adding a recto-intercostal fascial plane block to an existing external oblique intercostal plane block provides better pain relief after laparoscopic cholecystectomy in adults.

  Recruiting Ankara Etlik City Hospital · Ankara, Yenimahalle\Ankara · NCT07777172

• Electrical acupoint stimulation plus three anti-nausea drugs to prevent post-op nausea in high-risk women

  This trial will test whether adding wearable electrical acupoint stimulation to three anti-nausea drugs reduces postoperative nausea and vomiting in high-risk adult women having elective laparoscopic surgery.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07480785

• PEG bowel preparation effects on gut microbes after gallbladder removal

  This study tests whether PEG-based colonoscopy prep causes larger or longer-lasting changes to gut microbes in adults who have had their gallbladder removed compared with people who still have their gallbladder.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07439640

• Comparing laparoscopic ultrasound and fluorescence imaging with indocyanine green to map bile ducts during difficult laparoscopic gallbladder removal

  This will try two imaging methods—laparoscopic ultrasound and fluorescence cholangiography with indocyanine green—in adults having technically difficult laparoscopic gallbladder removal to see which shows the bile duct anatomy best.

  Recruiting Consorci Sanitari Integral · Sant Joan Despí, Barcelona · NCT07400237

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.