Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions
Primary Purpose
Pectus Excavatum, Pectus Carinatum
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Pectus Excavatum
Eligibility 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
Sites / Locations
- Medical University Innsbruck
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery
Arm Description
Patients suffering from Pectus excavatum and Pectus carinatum will be surgically treated
Outcomes
Primary Outcome Measures
Improvement of lung function from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT02163265
First Posted
March 21, 2014
Last Updated
May 25, 2021
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT02163265
Brief Title
Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions
Official Title
Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum, Pectus Carinatum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Patients suffering from Pectus excavatum and Pectus carinatum will be surgically treated
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Patients suffering from Pectus excavatum Pectus carinatum will be treated surgically according to normal procedures
Primary Outcome Measure Information:
Title
Improvement of lung function from baseline
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Del Frari, MD
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34263302
Citation
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.
Results Reference
derived
PubMed Identifier
33212487
Citation
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.
Results Reference
derived
PubMed Identifier
29092017
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions
We'll reach out to this number within 24 hrs