Status:
COMPLETED
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Funnel Chest
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.
Detailed Description
The secondary objectives are: * To measure the quality of life of patients operated on for pectus excavatum * Identify and describe post-operative complications * Follow-up on the body mass index cha...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03770390
Start Date
December 16 2018
End Date
December 31 2024
Last Update
September 30 2025
Active Locations (1)
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1
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, France, 34295