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 range
14 Years
Sex
ALL
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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))