RecruitingNAINTERVENTIONAL

Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease

This study is looking at two different surgical methods for removing the gallbladder: robotic surgery and conventional keyhole (laparoscopic) surgery. It's for adults who need their gallbladder removed due to common issues like gallstones or gallbladder polyps. The main goal is to see if robotic surgery is as safe as standard keyhole surgery by tracking any complications within 30 days after the operation. Researchers will also look at other things like how well patients recover, their quality of life, and the overall cost. This is an important step to understand if robotic surgery can be a good option for gallbladder removal in the future, providing valuable information for doctors and patients.

At a glance

Status

Recruiting

Phase

Sponsor

Portsmouth Hospitals NHS Trust

Enrolment target

276

Start

12 Sep 2025

Estimated completion

01 Jun 2026

Cholecystectomy, Robotic Cholecystectomy, Laparoscopic Cholecystectomy Gallstones Benign Gallbladder Disease

What is this study about?

Imagine you need your gallbladder removed, perhaps because of painful gallstones. Doctors often use a method called keyhole surgery (laparoscopic cholecystectomy), which involves a few small cuts. Now, a newer method using robotic assistance (robotic cholecystectomy) is also being explored. This study wants to find out if this robotic way of removing the gallbladder is just as good and safe as the traditional keyhole method for common gallbladder problems.

Researchers will involve around 276 adult patients who need their gallbladder removed. Half will have the surgery using robotic assistance, and the other half will have the standard keyhole surgery. The main thing they'll be checking is if there are any problems or complications after the surgery, within the first 30 days. They'll also look at how quickly patients recover, their overall quality of life after the operation, and the costs involved. This is the first time these two methods have been compared in this way through a careful study.

The information gathered from this study is really important. It will help doctors understand more about robotic surgery for gallbladder removal, helping them decide when it might be a suitable option and guiding how this technology is used in hospitals. Ultimately, this research aims to ensure that patients receive the best and safest care possible when undergoing gallbladder surgery.

Key takeaways

Compares robotic vs. standard keyhole surgery for gallbladder removal.
For adults with common gallbladder issues like gallstones.
Aims to check if robotic surgery is just as safe as keyhole surgery.
Patients will be randomly assigned to one of the two surgery types.
Follow-up for 30 days after surgery to monitor recovery and complications.
Helps doctors understand the best surgical options for gallbladder disease.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a common gallbladder problem like gallstones or polyps that doctors have seen on scans. You also need to be able to understand the study and agree to take part.

However, there are some reasons why you wouldn't be able to join. For example, if your surgeon thinks keyhole surgery isn't possible for you, or if you have an infection in your gallbladder at the time. Also, if there's any concern about cancer, if you're pregnant, or have severe liver disease, you wouldn't be able to participate.

Finally, if you have known stones in a tube called the common bile duct, or if language difficulties would make it hard to fill out quality of life questionnaires, this study wouldn't be right for you.

Quick self-check

Are you 18 years or older?
Do you need your gallbladder removed because of gallstones or polyps?
Do you NOT have an active gallbladder infection (acute cholecystitis)?
Are you NOT pregnant and do you NOT have severe liver disease?
Is your surgeon happy for you to have keyhole surgery?
Can you understand and answer questionnaires in English?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be randomly assigned to have your gallbladder removed using either robotic surgery or standard keyhole surgery – like flipping a coin, but done by a computer. You won't get to choose which type of surgery you have. You'll need to fill out some questionnaires about how you're feeling and your quality of life. Doctors will closely monitor you for any complications for 30 days after your operation.

You'll have follow-up checks at 7 days and 30 days after your surgery to see how you're recovering. The total duration of your active participation, including follow-up, would be about one month after your operation. The study doesn't involve any new or experimental medication, just two different surgical approaches.

Potential risks and benefits

Potential benefits of taking part could include receiving a carefully monitored surgical procedure by experienced teams, contributing to valuable medical knowledge that may help future patients, and potentially benefiting from the chosen surgical technique. As with any surgery, there are always potential risks, including those normally associated with gallbladder removal, such as infection, bleeding, or issues with anaesthesia, regardless of the method used. The study is designed to compare the safety of both methods. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Queen Alexandra Hospital
Portsmouth, United Kingdom· Recruiting

Common questions

What is a cholecystectomy?

It's the medical word for surgery to remove your gallbladder.

What are gallstones?

These are small, hard deposits that can form in your gallbladder and cause pain or other problems.

What's the difference between robotic and laparoscopic surgery?

Laparoscopic (keyhole) uses small cuts and special tools. Robotic surgery also uses small cuts but with the surgeon controlling robotic arms for more precise movements.

Will I get to choose which surgery I have?

No, you'll be randomly put into one of the two surgery groups, like drawing lots, to ensure the study is fair.

How long will I be involved in the study?

You'll be followed closely for 30 days after your surgery, with checks at 7 and 30 days.

How to find out more

Gijsbert I. van Boxel

g.vanboxel@nhs.net +44 023 9228 6000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.