Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions

NCT02163265 | Completed

• 2 other identifiers: 20130111-621KLI312
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum; Pectus Carinatum

Outcome Measures

Primary Outcomes (1)

• Improvement of lung function from baseline

  6 months after surgery

Study Arms (1)

Surgery

EXPERIMENTAL

Patients suffering from Pectus excavatum and Pectus carinatum will be surgically treated

Procedure: Surgery

Interventions

Surgery PROCEDURE

Patients suffering from Pectus excavatum Pectus carinatum will be treated surgically according to normal procedures

Surgery

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Related Publications (3)

• Del Frari B, Blank C, Sigl S, Schwabegger AH, Gassner E, Morawetz D, Schobersberger W. The questionable benefit of pectus excavatum repair on cardiopulmonary function: a prospective study. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):75-82. doi: 10.1093/ejcts/ezab296.

  PMID: 34263302 DERIVED

• Del Frari B, Sigl S, Schwabegger AH, Blank C, Morawetz D, Gassner E, Schobersberger W. Impact of surgical treatment of pectus carinatum on cardiopulmonary function: a prospective study. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):382-388. doi: 10.1093/ejcts/ezaa335.

  PMID: 33212487 DERIVED

• Sigl S, Del Frari B, Harasser C, Schwabegger AH. The effect on cardiopulmonary function after thoracoplasty in pectus carinatum: a systematic literature review. Interact Cardiovasc Thorac Surg. 2018 Mar 1;26(3):474-479. doi: 10.1093/icvts/ivx353.

  PMID: 29092017 DERIVED

MeSH Terms

Conditions

Funnel Chest; Pectus Carinatum

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cartilage Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Barbara Del Frari, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: June 13, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)