Evaluation of Chest Wall Motility After MIRPE

Summary

Pectus excavatum (PE) is the most common congenital deformity of the chest wall and surgical treatment using the minimally invasive technique (MIRPE) is consolidating as the choice to perform PE correction. In this technique, a temporary metal bar is placed in a retrosternal position, pushing the sternum without the need for cartilage resection. Despite the advantages obtained, it is not free from complications, with the displacement of the bar being one of the main problems. Therefore, the aim of this study is to evaluate a new bridging device for the set of two metal bars to be used in the surgical treatment of PE, verifying the clinical and surgical complications and evaluating the change in lung volumes and thoracoabdominal kinematics using optoelectronic plethysmography , preoperatively and 180 days after MIRPE; and also evaluating diaphragmatic mobility via ultrasound examination to assess the craniocaudal displacement of the left branch of the vein preoperatively and 180 days later. There will be 20 participants, who after performing a computed tomography of the chest to obtain the Haller index, clinical and laboratory tests, electrocardiogram and echocardiogram. Participants will be randomized and divided into two groups: 10 control individuals (traditional MIRPE technique used in the Service) and 10 intervention individuals (with bridge fixators developed in partnership with Traumec Tecnologia e Implantes, Brazil). The effectiveness of the fixators will be evaluated by the degree of displacement of the bars, using a mathematical formula, using a lateral chest X-ray in the immediate postoperative period (d0) and another image from the end of the period analyzed (dX), 15, 30, 90 and 180 days after the surgical procedure; evaluation of postoperative pain through the numerical pain scale; use of validated questionnaires on quality of life (physical and mental health) using two instruments, SF-36 and PEEQ. All data obtained between the two groups will be submitted to descriptive and inferential statistics.

Conditions

• Funnel Chest

Interventions

PROCEDURE

MIRPE with two bars

Minimally invasive repair of pectus excavatum utilizing two metallic bars

PROCEDURE

MIRPE with one bar

Minimally invasive repair of pectus excavatum utilizing one metallic bar

Sponsors & Collaborators

• Hospital Alemão Oswaldo Cruz

  collaborator OTHER

• Traumec Tecnologia e Implantes Ortopedicos Ltda

  collaborator UNKNOWN

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Miguel L Tedde, MD, PhD · Heart Institute (InCor) FMUSP

• Paulo M Pego-Fernandes, MD, PhD · Heart Institute (InCor) FMUSP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2022-10-30

Completion

2022-12-01

Countries

• Brazil

Study Locations