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CompletedNCT02163265Updated May 26, 2021

Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions

An interventional study of Surgery in Pectus Excavatum and Pectus Carinatum, sponsored by Medical University Innsbruck. Completed at 1 site in Austria. Open to participants aged 10 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
10 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Pectus Excavatum
  • Pectus Carinatum

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03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 for anaesthesia
  • body height less than 130 cm
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Surgery

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

    Procedure: Surgery

Interventions

  • ProcedureSurgery

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

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What researchers measure

Primary outcomes

  1. Improvement of lung function from baseline

    Time frame: 6 months after surgery

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Study locations

1 site
  • Medical University Innsbruck
    Innsbruck, 6020, Austria
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References and documents

Publications

  • 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. PubMed 34263302 ↗
  • 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. PubMed 33212487 ↗
  • 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. PubMed 29092017 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02163265
Responsible party
Barbara Del Frari, MD (Associate Professor, Medical University Innsbruck) — Principal investigator
First posted
Jun 13, 2014
Start date
Jul 2014
Primary completion
Dec 2020
Completion
Dec 2020
Last update
May 26, 2021

Study contacts

Barbara Del Frari, MD
principal investigator · Medical University Innsbruck

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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