A randomised trial of surgery versus no treatment to RESTORE cardiopulmonary function in severe pectus excavatum

South Tees Hospitals NHS Foundation Trust0 个研究点目标入组 300 人开始时间: 2024年4月30日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•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.

•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.

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