Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02163265 |
| Other study ID # |
20130111-621 |
| Secondary ID |
KLI312 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2014 |
| Est. completion date |
December 2020 |
Study information
| Verified date |
May 2021 |
| Source |
Medical University Innsbruck |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
