Cardiothoracic surgery, pectus excavatum Surgery
Conditions
Interventions
If a potential participant consents to the randomised trial, a series of screening and baseline assessments will be conducted and recorded. These include capturing data from routine care on medical hi
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 09/09/2025: For inclusion in the randomised trial: 1. = 12 years old. 2. A PE deformity with a Haller Index of >3.25, as measured by the internal width of the chest measured at the widest point divided by the distance from the back of the sternum to the anterior vertebral body at its minimum point on CT scan. 3. SF36V2 physical functioning score = 80 4. The participant must satisfy at least one of the following criteria: 4.1. Significant level of shortness of breath or exercise ability perceived to be below that of their peers (e.g., limited by vigorous activities such as running or lifting heavy objects). 4.2. Presyncope or syncope on exercise. 4.3. Arrhythmias on ECG that may be due to the pectus abnormality. 4.4. Dysphagia or swallowing abnormalities in the absence of any other cause. 5. Provide informed consent/assent and agree to 5 years of follow up. 6. Fit to undergo surgery. For inclusion in the observational cohort: 1. >=12 years old. 2. Confirmed as eligible and fit for surgery via the national MDT surgical pathway. 3. Providing informed consent to take part in the embedded observational cohort 4. SF36V2 physical functioning score = 80 Previous inclusion criteria: For inclusion in the randomised trial: 1. = 12 years old. 2. A PE deformity with a Haller Index of >3.25, as measured by the internal width of the chest measured at the widest point divided by the distance from the back of the sternum to the anterior vertebral body at its minimum point on CT scan. 3. The participant must satisfy at least one of the following criteria: 3.1. Significant level of shortness of breath or exercise ability perceived to be below that of their peers (e.g., limited by vigorous activities such as running or lifting heavy objects). 3.2. Presyncope or syncope on exercise. 3.3. Arrhythmias on ECG that may be due to the pectus abnormality. 3.4. Dysphagia or swallowing abnormalities in the absence of any other cause. 4. Provide informed consent/assent and agree to 5 years of follow up. 5. Fit to undergo surgery. For inclusion in the observational cohort: 1. >=12 years old. 2. Confirmed as eligible and fit for surgery via the national MDT surgical pathway. 3. Providing informed consent to take part in the embedded observational cohort and agreeing to 5 years follow up.
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 09/09/2025: For the randomised trial: 1. Patients not fulfilling the inclusion criteria. 2. Symptoms relating to causes other than PE. 3. Unwilling to have surgery for PE. For the observational cohort: 1. Patients not fulfilling the inclusion criteria. 2. Patients who are willing to join the full randomised trial group of the RESTORE Trial. 3. Received previous corrective surgery for PE (Nuss/Ravitch). Previous key exclusion criteria: For the randomised trial: 1. Patients not fulfilling the inclusion criteria. 2. Symptoms relating to causes other than PE. 3. Unwilling to have surgery for PE. For the observational cohort: 1. Patients not fulfilling the inclusion criteria. 2. Patients who are willing to join the full randomised trial group of the RESTORE Trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 26/11/2025: 1. Change in SF-36v2 Physical Function score between baseline and 1-year, using a 4-week recall period. Primary economic outcome 1. Cost effectiveness measured in terms of incremental cost per quality-adjusted life year (QALY) gained over 1-year following index surgery _____ Previous primary outcome(s): 1. SF-36v2 Physical Function score change between testing before randomisation and 1 year later (control group) or 1 year after surgery (experimental group). 2. Incremental cost per QALY at 1 year. QALY assessed through quality of life questionnaires (EQ-5D-5L, SF-36v2, HADS) completed at baseline and 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 26/11/2025: 1. Change in cardiopulmonary function between baseline and 1-year, assessed by percentage predicted VO2peak on CPET. Other secondary outcomes: 2. Measures of cardiopulmonary function by CPET and spirometry at 1-year and 3-years. 3. Quality of life measures, including those assessing mental well-being (EQ-5D-5L and SF-36v2 mental component scores) at 1-year and 3-years. 4. Anxiety and depression scores measured by HADS at 1-year and 3-years. 5. Symptoms measured by modified PEEQ and PCAPES questionnaires at 1-year and 3-years. 6. Body image measured by BIDQ at 1-year and 3-years. 7. Measures of technical operative success by Haller Index and Correction Index post-operatively. 8. Need for revision surgery (complications including unplanned redo surgery and syncope) to 1-year and 3-years. 9. Adverse events of special interest (related to PE, not the intervention) to 1-year and 3-years. 10. Major surgical complications to 1-year and 3-years. 11. Cost per participant, including intervention costs, healthcare and social care service costs, and out-of-pocket expenses for participants and their families/carers at 1-year post-intervention and over the participant’s lifetime. 12. Average QALYs per participant estimated from EQ-5D-5L and SF-6D (derived from SF-36v2) over 1-year. 13. Modelled costs and QALYs over the participant’s lifetime. 14. Modelled incremental cost per QALY gained over the participant’s lifetime. 15. Incremental net benefit of the intervention. 16. Participants’ willingness to pay for each intervention. _____ Previous key secondary outcome(s): 1. Measures of cardiopulmonary function from cardiopulmonary exercise tests (CPET), at baseline, 1 year (post-surgery for all groups and also post-randomisation for the late surgery group), 3 years post-surgery. 2. Quality of life measures including those that of impact on mental well-being (EQ-5D-5L and SF36v2 mental component scores, and HADS), at ba | — |
Countries
England, United Kingdom
Contacts
Public Contact. RESTORE trial team
Outcome results
None listed