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

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ClinicalTrials.gov Identifier: NCT02174796
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Pectus Excavatum Procedure: surgical treatment Procedure: orthopedic treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 2017
Actual Study Completion Date : July 2017

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.




Primary Outcome Measures :
  1. Cardiac output difference before and after intervention,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) ]
    Cardiac output measured by transthoracic impedancemetry, during an exercise stress test


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Exercise cardiac output [ 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) ]
    Exercise cardiac output (measured by transthoracic echocardiography)

  4. Quality of life [ 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) ]
    Quality of life SF36

  5. Mean energy expenditure [ 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) ]
    Mean energy expenditure will be evaluated by metabolic and physical activity monitor "armband" during 3 days (Kcal/min)

  6. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174796


Locations
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France
CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles
Clermont-Ferrand, France, 63000
Centre Jean Perrin
Clermont-Ferrand, France, 63011
CHU G Montpied, Service de Cardiologie et Maladies Vasculaires
Clermont-Ferrand, France, 63011
CHU de St Etienne, Hôpital Nord, Chirurgie thoracique
Saint-Priest en Jarez, France, 42055
CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles
St Etienne, France, 42100
Sponsors and Collaborators
Centre Jean Perrin
Investigators
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Principal Investigator: Marc Filaire, Pr Centre Jean Perrin, Service de Chirurgie Thoracique
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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT02174796    
Other Study ID Numbers: 2013-A01811-44
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Keywords provided by Centre Jean Perrin:
Pectus excavatum
cardiac output
transthoracic impedancemetry
Additional relevant MeSH terms:
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Funnel Chest
Congenital Abnormalities
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities