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

NCT ID: NCT02174796

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-05

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Pectus Excavatum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment group

patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).

intervention: surgical correction (Ravitch or Nuss type intervention).

Group Type EXPERIMENTAL

surgical treatment

Intervention Type PROCEDURE

patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).

Orthopedic treatment group

patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.

Group Type EXPERIMENTAL

orthopedic treatment

Intervention Type PROCEDURE

orthopedic treatment by vacuum bell.

Interventions

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surgical treatment

patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).

Intervention Type PROCEDURE

orthopedic treatment

orthopedic treatment by vacuum bell.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Filaire, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin, Service de Chirurgie Thoracique

Locations

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CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles

Clermont-Ferrand, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

CHU G Montpied, Service de Cardiologie et Maladies Vasculaires

Clermont-Ferrand, , France

Site Status

CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles

Saint-Etienne, , France

Site Status

CHU de St Etienne, Hôpital Nord, Chirurgie thoracique

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01811-44

Identifier Type: -

Identifier Source: org_study_id

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