CompletedInterventional

A randomised controlled trial comparing surgery with watchful waiting for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones

Gallstones are small stones that form inside the gallbladder. When they cause pain or nausea, doctors usually recommend keyhole surgery to take the gallbladder out. However, many people only ever experience one painful episode and may never need an operation. Surgery carries risks, requires recovery time, and costs the NHS money. This study compares two common treatment paths: having keyhole surgery to remove the gallbladder, or taking a watchful waiting approach. Watchful waiting involves managing any symptoms with painkillers and healthy lifestyle advice, saving surgery only for people whose symptoms persist or worsen. Participants are randomly placed into one of these two treatment groups and followed up for at least 18 months. Researchers track their quality of life, pain levels, and overall health to help the NHS decide which strategy works best for adults with uncomplicated gallstones.

At a glance

Status

Completed

Enrolment target

430

Start

01 Sep 2016

Estimated completion

01 Sep 2019

Gallstones

What is this study about?

Gallstones are very common in the UK. They are tiny pebbles, usually made of cholesterol, that form inside the gallbladder. For many people, gallstones cause no trouble at all. However, around one in three people develop sudden, severe tummy pain (known as biliary colic), sometimes alongside sickness. When this happens, doctors usually suggest an operation to take out the gallbladder, known as keyhole surgery. Over 70,000 of these operations are carried out across the NHS each year.

Even though surgery is standard, research shows that not everyone who has a gallstone attack goes on to have another one. For some, the pain never returns. This means some patients may be having operations, with all the usual surgical risks and recovery time, that they might not strictly need. An alternative is 'watchful waiting' or conservative care. This means using painkillers if pain flares up, making simple diet changes, and having surgery only if symptoms keep coming back.

This clinical trial aims to answer an important question: does surgery give patients a noticeably better quality of life than watchful waiting? By comparing both approaches across several NHS hospitals, researchers hope to see which option leads to fewer complications, better everyday wellbeing, and the most sensible use of NHS resources. The findings will help shape future national treatment guidelines for gallstones.

Key takeaways

Compares keyhole gallbladder removal with a 'watch and wait' approach.
Aimed at adults with confirmed, uncomplicated gallstone symptoms.
Participants are randomly assigned to either surgery or symptom management.
Involves filling out quality-of-life questionnaires over at least 18 months.
Helps the NHS determine whether surgery is always necessary for gallstone pain.

Who may be eligible?

This trial is for adults who have been referred by their GP to a hospital specialist because of painful gallstones. To take part, your gallstones must be confirmed by an ultrasound scan or another hospital imaging test. You also need to be generally well enough to have keyhole surgery if required.

The study is only open to people with 'uncomplicated' gallstones. This means you cannot join if stones have travelled into your main bile duct, or if you have had serious complications like an inflamed pancreas (pancreatitis), a burst gallbladder, or abnormal liver function tests.

You will also not be able to take part if you are pregnant, have had major open surgery on your upper tummy in the past, or have severe underlying health conditions that make general anaesthetics unsafe. Your hospital care team will check your medical history to make sure taking part is safe for you.

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 aged 18 or older?
Have you had tummy pain caused by gallstones?
Have your gallstones been confirmed by an ultrasound or scan?
Are you free of serious complications like pancreatitis or bile duct blockages?
Have you avoided major open surgery on your upper tummy in the past?
Are you currently not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly place you into one of two groups. One group will have standard NHS keyhole surgery to remove the gallbladder. The other group will follow a watchful waiting plan, managing symptoms with painkillers and lifestyle advice, with surgery kept as an option if pain returns. Both groups receive standard NHS care throughout. The study follows you for at least 18 months. During this time, you will be asked to fill in questionnaires about your symptoms, everyday activities, and general quality of life. Aside from completing these surveys, your appointments and medical checks will be very similar to regular NHS care.

Potential risks and benefits

Taking part does not add any extra medical risks beyond the normal care you would receive for gallstones. Keyhole surgery carries standard surgical risks, such as wound infection, bleeding, or reactions to general anaesthetic. The watchful waiting approach carries the risk that your pain might come back, meaning you may need surgery later on. While taking part may not directly change your outcome, your involvement will provide vital evidence to help the NHS decide the best care for future patients. You are entirely free to withdraw from the study at any time without your regular NHS treatment being affected.

Locations (20)

NHS Grampian
Approximate
Aberdeen, Scotland
Taunton and Somerset NHS Foundation Trust
City only
Taunton, England
Nottingham University Hospital NHS Trust
City only
Nottingham, England
Royal Free Hospital
Approximate
London, England
Queen Elizabeth University Hospital
Approximate
Glasgow, Scotland
Royal Gwent Hospital
Unverified
Newport, Wales
Coventry University Hospital
Unverified
Coventry, England
North Tees University Hospital
Unverified
Stockton-on-Tees, England
Plymouth Hospitals NHS Trust
Unverified
Plymouth, England
University Hospital Aintree NHS Trust
Unverified
Liverpool, England
Ninewells Hospital and Medical School
Unverified
Dundee, Scotland
Royal Liverpool University Hospital
Unverified
Liverpool, England

Common questions

What is the difference between surgery and watchful waiting?

Surgery removes the gallbladder so stones cannot cause pain again. Watchful waiting means monitoring your symptoms, using painkillers if pain flares up, and only operating if problems continue.

Can I live a normal life without a gallbladder?

Yes. The gallbladder stores digestive fluid (bile), but your liver makes it. Without a gallbladder, bile flows straight into your gut, and most people live completely normal, healthy lives.

Can I choose which treatment group I join?

No. A computer assigns you to a group at random. This is done to make sure the comparison between surgery and watchful waiting is completely fair and accurate.

What happens if my pain gets worse during watchful waiting?

If your pain returns frequently or becomes severe, your hospital doctor can arrange for you to have surgery to remove your gallbladder.

Will taking part cost me anything?

No. All treatments, tests, and hospital appointments are provided through the NHS as part of your standard healthcare.

How to find out more

Karen Innes

kareninnes@abdn.ac.uk +44 (0)1224 438089 Official trial record

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