The RESTORE Trial

IRAS number; 331910

ISRCTN; 11359779

Why is this research being done?

People with severe pectus excavatum (PE), can have 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, which relieves these symptoms. High-quality data showing that surgery improves physical health and heart-lung function is limited. The purpose of this study is to see how surgery to treat PE affects a participant’s ability to be physically active.

What happens to me if I agree to take part in this research?

If you decide to take part in this research study, you will be allocated to undergo surgery as soon as possible (within 3 months) or with a year’s delay. The group you are allocated to will be chosen randomly by a computer (like tossing a coin). There is equal chance of being allocated to each group. Your health will then be followed up for a period of up to about 4 years. During this time, you will be asked about your health, to do exercise tests and to complete questionnaires.

If you have been diagnosed with very severe PE and you have already been told that you are eligible for surgery by the national expert group, then you can instead choose to have your surgery as scheduled and take part in our observational arm of the study. In this, similar to the trial arm of the research, we would collect data from your medical records and follow your health for about 4 years, asking you to do exercise tests and complete questionnaires.

Your journey through the study

Visual aid outlining the patient journey (81.12kB, PPTX)

How many people will take part in this research?

We are looking for 200 people to be split evenly between early or late surgery arms of the research.

And another 100 people in the observational arm.

At which hospitals will the study take place?

We are aiming to have around 12 to 15 hospitals across the UK taking part in the study. Below is a list of sites already open to recruitment. More sites will be opened in the coming months.

The James Cook University Hospital, Middlesbrough

Surgeon: Mr Joel Dunning
Contact: [email protected]
Status: Open to recruitment

Can I take part in the study?

We are looking for people aged 12 and upwards who have been diagnosed with pectus excavatum and a Haller Index of more than 3.25 (Haller index is a measure of how severe the pectus excavatum is). There are some additional criteria you will need to meet to take part, please speak with your usual care team about this study. 

How do I take part in the study?

In the first instance, please speak with your usual care team or contact your closest hospital as shown in the table. They will be able to provide you with more information about the trial and what taking part will mean. You can also email the central study team at [email protected]

Further information can be found in the participant information sheets: 

Who is organising and funding the study?

Funding has been provided by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (read more about the NIHR, who they are and what they fund on the NIHR website).

The Academic Cardiovascular Unit at South Tees Hospitals NHS Foundation Trust is organising this study.  

South Tees Hospitals NHS Foundation Trust is the ‘Sponsor’ of this study, meaning they are legally responsible. 

The study has been reviewed and given a favourable ethical opinion (ethical approval) by the East of Scotland Research Ethics Service (EoSRES) Ethics Committee.

Trial research team

Co-chief investigators: 

• Professor Enoch Akowuah, consultant cardiothoracic surgeon, The James Cook University Hospital Middlesbrough 
• Mr Joel Dunning, consultant thoracic surgeon, The James Cook University Hospital Middlesbrough 

ACU team: 

• Dr Leanne Ayrton-Marsay, senior research manager 
• Dr Lisa Chang, principal research manager 
• Helen Geoghegan, research coordinator

Wider research team

• Prof James Wason, professor of biostatistics at Newcastle University  
• Dr Thomas Chadwick, senior statistician at Newcastle University.  
• Prof Luke Vale professor of health economics at The London School of Hygiene and Tropical Medicine.  
• Dr Cristina Fernandez-Garcia, research associate, Health Economics Group at Newcastle University. 
• Rebecca Maier, head of the academic cardiovascular and thoracic unit at South Tees Hospitals NHS Foundation Trust.  
• Mr James Andrews, consultant paediatric surgeon at Glasgow Children’s Hospital.  
• Prof Jonathan Wyllie, consultant paediatrician at South Tees Hospitals NHS Foundation Trust.  
• Dr Gillian Wallace, consultant in respiratory medicine at North Tees University Hospital.  
• Prof Gerard Danjoux consultant anaesthetist at South Tees Hospitals NHS Foundation Trust.  
• Mr Babu Naidu, consultant thoracic surgeon and clinical senior lecturer at University Hospital Birmingham.  
• Dr Rebecca Thursfield, paediatric respiratory consultant, Alder Hey Children’s Hospital. 
• Prof Peter McCulloch, chair of IDEAL Collaboration, Oxford University.  
• Mr Philip Longhurst, patient representative for the RESTORE Trial. 
• Dr Claire Pryor, patient representative for the RESTORE Trial. 

Current study status

Recruiting until August 2026.