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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-16

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Funnel Chest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This single group study documents changes before and after surgical correction of pectus excavatum.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The study population

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

Group Type OTHER

Surgical correction of pectus excavatum

Intervention Type PROCEDURE

Surgical correction of pectus excavatum

Interventions

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Surgical correction of pectus excavatum

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No