Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

Not Applicable

Completed

• Conditions: Pectus Excavatum
• Interventions: Procedure: surgical treatment; Procedure: orthopedic treatment

• Registration Number: NCT02174796
• Lead Sponsor: Centre Jean Perrin

Brief Summary

this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-23
• Study Start: 2014-05-05
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Primary Completion: 2017-02
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Patients seeking treatment of a pectus excavatum
• Haller index > 3.2
• Desire for treatment
• age between 15 and 40 years old

Exclusion Criteria

• Cognitive impairment
• Pregnancy
• Contraindication to exercise stress test or general anesthesia
• Coagulation disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment group	surgical treatment	patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention).
Orthopedic treatment group	orthopedic treatment	patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.

Primary Outcome Measures

Name	Time	Method
Cardiac output difference before and after intervention,during an exercise stress test	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)	Cardiac output measured by transthoracic impedancemetry, during an exercise stress test

Secondary Outcome Measures

Name	Time	Method
Rest lung function tests	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Quality of life	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)	Quality of life SF36
Evaluation of postoperative neuropathic pain	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Mean energy expenditure	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)	Mean energy expenditure will be evaluated by metabolic and physical activity monitor "armband" during 3 days (Kcal/min)
Exercise functional capacity	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Exercise cardiac output	4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)	Exercise cardiac output (measured by transthoracic echocardiography)

Trial Locations

Locations (5)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles; 🇫🇷 Clermont-Ferrand, France

CHU G Montpied, Service de Cardiologie et Maladies Vasculaires; 🇫🇷 Clermont-Ferrand, France

CHU de St Etienne, Hôpital Nord, Chirurgie thoracique; 🇫🇷 Saint-Priest en Jarez, France

CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles; 🇫🇷 St Etienne, France