ISRCTN11359779
Active, not recruiting
未知
A randomised trial of surgery versus no treatment to RESTORE cardiopulmonary function in severe pectus excavatum
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cardiothoracic surgery, pectus excavatum
- Sponsor
- South Tees Hospitals NHS Foundation Trust
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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