RESTORE
Research type
Research Study
Full title
A randomised trial of surgery versus no treatment to RESTORE cardiopulmonary function in severe pectus excavatum.
IRAS ID
331910
Contact name
Enoch Akowuah
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN11359779
Duration of Study in the UK
6 years, 4 months, 15 days
Research summary
Pectus Excavatum (PE), also known as funnel chest, is a condition where the ribs and breastbone grow inwards forming a dent in the chest. It can be found in between 1 in 400 and 1 in 1000 people. People with severe PE, where the space between the spine and the chest is limited, can experience symptoms such as breathlessness, dizziness, fainting and pain with exercising. This can be very restrictive in daily life.
Treatment for PE includes surgery, which lifts the sternum up, relieving these symptoms. There are no new or “experimental” procedures being tested in this study: the two types of surgeries called the Nuss and Ravitch procedures are both well-established and regularly performed in patients across the world.
In 2019 the NHS England decommissioned pectus surgery, although it is still fully-funded in the devolved nations. This decision was based on the lack of high-quality comparative data showing an improvement in physical health or heart-lung function. More recently in 2023, NHS England have started funding surgery for only the most severe cases, as assessed by a national expert Multi-Disciplinary Team (MDT), which are then performed at two hospitals in England.
The purpose of this study is to see how surgery to treat PE affects a participant’s ability to be physically active. We will recruit 300 participants overall and compare the risks and benefits of surgery against no surgery as measured by a change in physical health after a year. We will also look at how much it costs the NHS overall.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0034
Date of REC Opinion
3 Jun 2024
REC opinion
Further Information Favourable Opinion