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

• Sponsor: Centre Jean Perrin (Other)
• Overall Status: Completed
• CT.gov ID: NCT02174796
• Collaborator: (none)
• Enrollment: 41
• Locations: 5
• Arms: 2
• Actual Duration (Months): 37.9
• Patients Per Site: 8.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum	Procedure: surgical treatment; Procedure: orthopedic treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
• Actual Study Start Date: May 5, 2014
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical treatment group patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention).	Procedure: surgical treatment; patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
Experimental: Orthopedic treatment group patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.	Procedure: orthopedic treatment; orthopedic treatment by vacuum bell.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)]

2. 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)]

3. 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)

4. 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

5. 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)

6. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles	Clermont-Ferrand		France	63000
2	Centre Jean Perrin	Clermont-Ferrand		France	63011
3	CHU G Montpied, Service de Cardiologie et Maladies Vasculaires	Clermont-Ferrand		France	63011
4	CHU de St Etienne, Hôpital Nord, Chirurgie thoracique	Saint-Priest en Jarez		France	42055
5	CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles	St Etienne		France	42100

Sponsors and Collaborators

• Centre Jean Perrin

Investigators

• Principal Investigator: Marc Filaire, Pr, Centre Jean Perrin, Service de Chirurgie Thoracique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Jean Perrin
• ClinicalTrials.gov Identifier: NCT02174796
• Other Study ID Numbers: 2013-A01811-44
• First Posted: Jun 26, 2014
• Last Update Posted: Jul 19, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by Centre Jean Perrin: Pectus excavatum; cardiac output; transthoracic impedancemetry
• Additional relevant MeSH terms: Funnel Chest

Study Results

No Results Posted as of Jul 19, 2017