Assessing heart and lung function after surgery for funnel chest
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
This study is testing how surgery for funnel chest affects heart and lung function and quality of life in patients who have had the surgery or are about to have it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT03770390 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the improvements in cardiorespiratory function and quality of life in patients who have undergone surgical correction for pectus excavatum, commonly known as funnel chest. It will measure postoperative complications, changes in body mass index, and intraoperative hemodynamic parameters. Patients who have had surgery within the last four years or are scheduled for surgery will be included in the study, with follow-up assessments planned to track their recovery and health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with pectus excavatum who are either scheduled for corrective surgery or have had surgery within the past four years.
Not a fit: Patients who are pregnant, lactating, or unable to provide consent, as well as those participating in other interventional protocols, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the benefits of surgical correction for patients with funnel chest, potentially improving their quality of life and health outcomes.
How similar studies have performed: While there may be studies on surgical outcomes for pectus excavatum, this specific focus on cardiorespiratory assessment and quality of life post-surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Montpellier
- Hôpital Arnaud de Villeneuve - CHU de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Laurence Solovei, MD — University Hospitals of Montpellier, France
- Study coordinator: Laurence Solovei, MD
- Email: l-solovei@chu-montpellier.fr
- Phone: +33.(0)4.67.33.62.70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.