Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities (PECTUS)
Primary Purpose
Pectus Excavatum
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgical treatment
orthopedic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Pectus Excavatum focused on measuring Pectus excavatum, cardiac output, transthoracic impedancemetry
Eligibility Criteria
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
Sites / Locations
- CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles
- Centre Jean Perrin
- CHU G Montpied, Service de Cardiologie et Maladies Vasculaires
- CHU de St Etienne, Hôpital Nord, Chirurgie thoracique
- CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Surgical treatment group
Orthopedic treatment group
Arm Description
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention).
patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.
Outcomes
Primary Outcome Measures
Cardiac output difference before and after intervention,during an exercise stress test
Cardiac output measured by transthoracic impedancemetry, during an exercise stress test
Secondary Outcome Measures
Rest lung function tests
Exercise functional capacity
Exercise cardiac output
Exercise cardiac output (measured by transthoracic echocardiography)
Quality of life
Quality of life SF36
Mean energy expenditure
Mean energy expenditure will be evaluated by metabolic and physical activity monitor "armband" during 3 days (Kcal/min)
Evaluation of postoperative neuropathic pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02174796
Brief Title
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
Acronym
PECTUS
Official Title
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 5, 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
Pectus excavatum, cardiac output, transthoracic impedancemetry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical treatment group
Arm Type
Experimental
Arm Description
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
intervention: surgical correction (Ravitch or Nuss type intervention).
Arm Title
Orthopedic treatment group
Arm Type
Experimental
Arm Description
patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.
Intervention Type
Procedure
Intervention Name(s)
surgical treatment
Intervention Description
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
Intervention Type
Procedure
Intervention Name(s)
orthopedic treatment
Intervention Description
orthopedic treatment by vacuum bell.
Primary Outcome Measure Information:
Title
Cardiac output difference before and after intervention,during an exercise stress test
Description
Cardiac output measured by transthoracic impedancemetry, during an exercise stress test
Time Frame
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)
Secondary Outcome Measure Information:
Title
Rest lung function tests
Time Frame
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)
Title
Exercise functional capacity
Time Frame
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)
Title
Exercise cardiac output
Description
Exercise cardiac output (measured by transthoracic echocardiography)
Time Frame
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)
Title
Quality of life
Description
Quality of life SF36
Time Frame
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)
Title
Mean energy expenditure
Description
Mean energy expenditure will be evaluated by metabolic and physical activity monitor "armband" during 3 days (Kcal/min)
Time Frame
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)
Title
Evaluation of postoperative neuropathic pain
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Filaire, Pr
Organizational Affiliation
Centre Jean Perrin, Service de Chirurgie Thoracique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHU G Montpied, Service de Cardiologie et Maladies Vasculaires
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHU de St Etienne, Hôpital Nord, Chirurgie thoracique
City
Saint-Priest en Jarez
ZIP/Postal Code
42055
Country
France
Facility Name
CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles
City
St Etienne
ZIP/Postal Code
42100
Country
France
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
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