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

Centre Jean Perrin

Status: Completed

Conditions: Pectus Excavatum

Treatments: Procedure: orthopedic treatment; Procedure: surgical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02174796

2013-A01811-44

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Surgical treatment group

Experimental group

Description:

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

Treatment:

Procedure: surgical treatment

Orthopedic treatment group

Experimental group

Description:

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

Treatment:

Procedure: orthopedic treatment