Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Mal… (NCT03770390) | Clinical Trial Compass
CompletedNot Applicable
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
France43 participantsStarted 2018-12-16
Plain-language summary
The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.
Who can participate
Age range14 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with pectus excavatum
* The patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery during the inclusion period
* Collection of informed written consent (patient and legal guardian, if applicable)
* Obligation of affiliation or beneficiary of a social security programme
Exclusion Criteria:
* Impossibility for the patient to participate in his/her next annual follow-up visit
* Absence of exercise test data AND respiratory function test data performed during the preoperative check-up
* Subject in exclusion period required by another protocol
* Pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
* Subject deprived of liberty by judicial or administrative decision
* Participation of the subject in another interventional protocol
* Failure to properly inform the patient (e.g. a language barrier)
What they're measuring
1
Change in: Oxygen pulse (mL O2 / heart beat)
Timeframe: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))