Clinical trial NCT02163265: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pectus Excavatum
Pectus Carinatum
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of lung function from baseline
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
affiliation: Medical University Innsbruck
name: Barbara Del Frari, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.