CompletedInterventional

Non-operative treatment of children with appendicitis vs appendectomy

Appendicitis is the most common emergency surgical condition in children. The standard treatment is an operation called an appendicectomy to remove the appendix under general anaesthetic. While this is a common procedure, surgery always carries small risks and can be stressful for children and parents. This study, funded by the NHS research arm (NIHR), looks at whether antibiotics are a safe and effective alternative to surgery. Children aged 4 to 15 with sudden, uncomplicated appendicitis are randomly placed into one of two groups. One group has the standard operation. The other group receives antibiotics through a vein and then by mouth. Doctors watch all children closely in hospital. If a child receiving antibiotics does not improve, they can still have the operation right away. The study will track both groups for one year to see how well they recover.

At a glance

Status

Completed

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

376

Start

31 Jan 2022

Estimated completion

31 Mar 2026

Appendicitis

What is this study about?

Acute appendicitis happens when the appendix, a small pouch attached to the gut, suddenly becomes swollen and infected. It is the most common reason a child needs emergency surgery. The usual treatment is an operation to remove the appendix, known as an appendicectomy. Most children recover quickly from surgery, but operations always carry risks like wound infections, bleeding, and the need for a general anaesthetic. Having an emergency operation can also feel frightening for both the child and their family.

Doctors want to find out whether antibiotics alone could treat appendicitis just as well, without needing surgery. Recent research shows that antibiotics successfully clear the infection for most children with early, uncomplicated appendicitis. However, we do not yet have enough clear evidence to prove whether this is safe, reliable, and better in the long run for children across the UK.

This trial, called CONTRACT 2, compares the two approaches directly. Half of the young patients will receive the usual surgery, and half will receive antibiotics. By following children over 12 months, researchers hope to see if antibiotic treatment leads to faster recovery, fewer complications, and a better experience for families, while also saving NHS resources.

Key takeaways

The study compares standard surgery with antibiotic treatment for children with appendicitis.
Open to children aged 4 to 15 diagnosed with early, uncomplicated appendicitis.
A computer randomly decides whether your child receives surgery or antibiotics.
Children on antibiotics who do not get better will still have an operation safely.
Children are monitored in hospital and checked on for 12 months after returning home.

Who may be eligible?

This study is open to children and teenagers aged 4 to 15 who arrive at hospital with sudden, uncomplicated appendicitis that would normally need an operation. Both the parents and the child (where appropriate) must agree to take part.

Children cannot take part if their appendicitis is already complicated. This includes cases where the appendix has burst (perforated), where there is a collection of pus or an inflammatory lump (an appendix mass), or if the child has had appendicitis before. Children with severe allergies to standard antibiotics, high risks from anaesthesia, or who are pregnant are also unable to join.

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.

My child is between 4 and 15 years old.
My child has been diagnosed with acute, uncomplicated appendicitis.
My child's appendix has not burst or formed a hard lump.
My child has not had appendicitis treated without surgery in the past.
My child does not have a severe allergy to the antibiotics being used.

Answer every question to see your result.

What does participation involve?

If you and your child agree to join, a computer will randomly place your child into one of two treatment groups. One group will have the standard operation to remove the appendix under general anaesthetic. The other group will be treated with antibiotics, starting through a small tube in a vein (a drip) and then switched to medicine taken by mouth.

Children in both groups stay in hospital and are checked frequently by medical teams to make sure they are improving. Once your child is eating, drinking, taking regular pain relief by mouth, and moving around comfortably, they can go home. Follow-up appointments will happen at 6 weeks, and then at 4, 8, and 12 months after leaving hospital. At these visits, parents will be asked to fill in brief questionnaires about their child's health and recovery. The total time in the study is one year.

Potential risks and benefits

Children having surgery benefit from a proven cure, meaning appendicitis cannot return. However, surgery carries minor risks such as wound infection, bleeding, reactions to anaesthetic, and in rare cases, gut blockage. There is also a 10% chance the removed appendix looks healthy, meaning the surgery was not strictly needed. Children having antibiotics may avoid an operation altogether and get back to normal life sooner. The main risks of antibiotics are that the infection might not clear (around 3 in 100 cases), requiring surgery anyway, or the appendicitis could return in the future. Joining the study is completely voluntary. You can withdraw your child at any time, and doing so will not affect the high standard of care they receive from the NHS.

Locations (24)

University Hospital Southampton
City only
Southampton, England
Royal Liverpool Childrens Hospital
City only
Liverpool, England
St George's Hospital
Approximate
London, England
United Leeds Teaching Hospitals NHS Trust
City only
Leeds, England
Bristol Childrens Hospital
Approximate
Bristol, England
Great North Children’s Hospital
Unverified
Newcastle, England
Chelsea & Westminster Hospital
Unverified
London, England
Leicester Royal Infirmary
Unverified
Leicester, England
Cardiff Hospital
Unverified
Cardiff, Wales
Evelina London Children's Hospital
Unverified
London, England
Kings College Hospital
Unverified
London, England
The Royal Belfast Hospital for Sick Children
Unverified
Belfast, Northern Ireland

Common questions

Can I choose whether my child gets antibiotics or surgery?

No. To make the trial fair and accurate, a computer randomly chooses which treatment your child receives, giving each child an equal chance of either option.

What happens if the antibiotics do not work?

Your child is watched very closely by doctors and nurses. If their symptoms do not improve or get worse, they will be taken for surgery to remove the appendix immediately.

Can appendicitis come back after antibiotic treatment?

Yes. Because the appendix is not removed, there is a small chance appendicitis could happen again later. If it does, the appendix can be removed at that time.

Will taking part delay my child's treatment?

No. Treatment begins promptly once a diagnosis is made and you have had time to ask questions and decide whether to join.

What if I change my mind later?

You are free to stop participating at any point. Your child will always receive standard NHS treatment, and your decision will not affect their ongoing care.

How to find out more

Jessica Kelly

jessica.kelly@soton.ac.uk +44 (0)2381205556 Official trial record

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