CompletedNot SpecifiedInterventional

Surgical Techniques: Robotic versus conventional Laparoscopic cholecystectomy IN benign Gallbladder disease (STARLING Trial)

The STARLING trial is a study looking at two types of keyhole surgery for removing gallbladders: robotic surgery and standard laparoscopic (keyhole) surgery. Many people now have robotic surgery for gallbladder issues, but there hasn't been a direct comparison between these two methods. This study aims to find out if robotic surgery is at least as safe and works just as well as the standard keyhole operation for non-serious gallbladder problems. Researchers will check for complications shortly after surgery, track how patients recover, look at their quality of life, and consider the costs involved. It's for adults with common gallbladder conditions needing surgery, and there are follow-up checks after 7 and 30 days.

At a glance

Status

Completed

Phase

Not Specified

Sponsor

Portsmouth Hospitals University NHS Trust

Enrolment target

276

Start

18 Aug 2025

Estimated completion

01 Jun 2026

Robotic versus conventional laparoscopic cholecystectomy in benign gallbladder disease

What is this study about?

You may have heard of keyhole surgery for removing gallbladders. This is a common operation. The STARLING trial is looking at two ways this surgery can be done: using a robot to help the surgeon (called robotic multi-port cholecystectomy) or the more traditional keyhole method (called conventional laparoscopic cholecystectomy).

Doctors want to know if performing gallbladder surgery with robotic assistance is as safe and effective as the standard keyhole operation. Even though robotic surgery is becoming more common, there haven't been many studies directly comparing these two methods. This research will help doctors understand if one method is better or if they are generally quite similar in terms of patient recovery and how well they work.

This study is important because it will give doctors clearer information to help them decide the best way to do gallbladder surgery for people with common, non-serious gallbladder problems. It will help ensure patients receive the best possible care.

Key takeaways

Compares two types of keyhole gallbladder surgery.
For adults with common, non-serious gallbladder problems.
Aims to see if robotic surgery is as safe and effective.
Will monitor recovery, complications, and quality of life.
No additional risks or benefits from participating.
Follow-up at 7 and 30 days after surgery.

Who may be eligible?

You might be able to join this study if you are 18 years old or older and have a common gallbladder problem like gallstones or a growth (polyp) in your gallbladder that shows up on a scan. You also need to be able to understand the study and agree to take part.

However, you won't be able to join if your surgeon thinks keyhole surgery isn't suitable for you. You also cannot participate if you have an urgent gallbladder infection that needs immediate surgery, or if you have known stones in your main bile duct. If doctors think there might be a chance of cancer, or if you are pregnant, or have severe liver disease, you also won't be able to join. Finally, if you have difficulty understanding or speaking English well enough to answer questions about your quality of life, you won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have gallstones or a gallbladder polyp diagnosed by a scan?
Can you understand and agree to take part in the study?
Are you NOT pregnant?
Do you NOT have an urgent gallbladder infection needing immediate surgery?
Do you NOT have severe liver disease (stage III or IV)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to have one of two types of keyhole gallbladder surgery: either robotic-assisted surgery or standard keyhole surgery. This is like flipping a coin – it's completely by chance which type you'll have. Both types of surgery are routinely performed.

The main things the study will look at are any complications that might happen within 30 days after your operation. They will also check how you recover generally, how often you need to use healthcare services, and how your quality of life is affected. You'll have follow-up checks after 7 days and again after 30 days following your surgery. These might involve a visit or a phone call to see how you're doing and to answer some questions about your health and recovery.

Potential risks and benefits

There are no extra risks or benefits from taking part in this study. Both the robotic-assisted and standard keyhole surgeries are already common procedures offered at the hospital. This study simply compares these two existing methods. You will receive the usual care you would expect for your gallbladder condition, regardless of whether you are in the study or not. Remember, you are free to stop participating in the study at any time without affecting your medical care.

Locations (1)

Queen Alexandra Hospital
Approximate
Portsmouth, United Kingdom

Common questions

What is the study called?

The study is called the STARLING Trial.

What kind of surgery are they comparing?

They are comparing standard keyhole gallbladder surgery with keyhole surgery where a robot helps the surgeon.

Who can be in the study?

Adults aged 18 and over with common gallbladder problems needing surgery can be considered.

Where is the study happening?

The study is taking place at Queen Alexandra Hospital in the UK.

Are there any extra risks if I join?

No, there are no extra risks as both types of surgery are already standard procedures.

How to find out more

Gijsbert I. van Boxel

g.vanboxel@nhs.net +44 (0)23 9228 6000 Official trial record

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