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Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163265
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Barbara Del Frari, MD, Medical University Innsbruck

Brief Summary:

Pectus excavatum or carinatum are the most common congenital deformations of the ventral thoracic wall. Several different surgical methods with different techniques to correct these deformations have been described.

Some clinicians recommend a correction of the deformation to improve the cardiopulmonary efficiency. Other think that the correction has a more an aesthetic than a physiological benefit.

The aim of our prospective study is to evaluate whether patients with PE or PC are suffering preoperatively from a cardiopulmonary limitation at rest and under physical stress and if there is a change of cardiopulmonary function after the surgical correction.


Condition or disease Intervention/treatment Phase
Pectus Excavatum Pectus Carinatum Procedure: Surgery Not Applicable

Detailed Description:

Pectus excavatum (PE) and pectus carinatum (PC) are the most common anterior chest wall deformities. Pectus excavatum, also known as funnel chest, is characterised by a deep depression usually involving the lower one-half to two-thirds of the sternum. PE is the most common congenital chest deformity and has a reported incidence of between 1:1000 and 8:1000 live births, with a male-to-female ratio of 3:1. Pectus carinatum, or pigeon breast, refers to protrusion of the sternum and is approximately seven times less frequent than PE, affecting 1:1000 to 1:10,000 live births. More than 26% have familial occurrence. The anatomic deformity is believed by many to be caused by a disproportionate growth of the costal cartilages as compared with the remainder of the bony thoracic skeleton, which exerts pressure on the sternum to cause depression (PE) and protrusion (PC). Although the majority of patients with PE are recognized during the first year of life, the depression usually becomes much more severe during childhood and adolescence; PC usually manifests itself at the time of a growth spurt in the early teenage years.

The deformities frequently present not only as an aesthetic disturbance, but also in association with mild limitation of activity, obstructive pulmonary mechanics, slight dyspnea, asthma, palpitations and abnormal cardiac physiology. Symptoms in PC patients remain often vague. PC patients usually complain more about the appearance of their chest rather than any functional difficulties. Chest wall deformities cause great social timidity, a sense of shame and often a feeling of limited self-worth and inferiority, depressive mood and inadequate social behaviour due to their disturbed body perception.

The results the investigators want to achieve with postoperative PFTs will demonstrate an improvement in total lung capacity and improved exercise performance and will show that both the restricted cardiac stroke volume and the increased work of breathing that have been described in PE patients can be ameliorated by operative intervention. These results will also contribute establish the criteria for the indication for surgery. The significant quality-of-life improvements perceived in psychosocial and physical functioning will encourage physicians to approach PE repair in the same manner as physicians do treatment of other deformities that have a deleterious impact on the psychological and physical well-being of the individual. Systematic evaluation of body image should become a diagnostic standard in the assessment of patients presenting themselves for correction of thoracic wall deformities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions
Study Start Date : July 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery
Patients suffering from Pectus excavatum and Pectus carinatum will be surgically treated
Procedure: Surgery
Patients suffering from Pectus excavatum Pectus carinatum will be treated surgically according to normal procedures




Primary Outcome Measures :
  1. Improvement of lung function from baseline [ Time Frame: 6 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • both women and men aged between 10 and 50 suffering from Pectus excavatum or Pectus carinatum

Exclusion Criteria:

  • patients suffering from Poland Syndrome
  • patients who already had a surgical PE corrections
  • other surgical treatments of the thorax
  • congenital heart defect
  • existing contra-indication for anaesthesia
  • body height less than 130 cm

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): NCT02163265


Locations
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Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Barbara Del Frari, MD Medical University Innsbruck
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barbara Del Frari, MD, Associate Professor, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02163265    
Other Study ID Numbers: 20130111-621
KLI312 ( Other Grant/Funding Number: FWF - Der Wissenschaftsfond )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Funnel Chest
Pectus Carinatum
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Cartilage Diseases
Connective Tissue Diseases