Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations (HeartSoar)

University Hospital Center (CHU)

Status: Completed

Conditions: Funnel Chest

Treatments: Procedure: Surgical correction of pectus excavatum

Study type: Interventional

Funder types: Other

Identifiers

NCT03770390

RECHMPL18_0184

2018-A01574-51 (Registry Identifier)

Details and patient eligibility

About

The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

Full 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 changes post-surgery
• Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively

Enrollment: 43 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

The study population

Other group

Description:

Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period. Intervention: Surgical correction of pectus excavatum

Treatment:

Procedure: Surgical correction of pectus excavatum