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Evaluation of Chest Wall Motility After MIRPE

NCT ID: NCT05124626

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Population to be studied: 20 individuals with pectus excavatum will be selected to undergo minimally invasive repair of pectus excavatum (MIRPE). Participants will be randomized into two groups: control and intervention group. In the latter, two metal bars and the bridge model fastener will be used as proposed in this study.

The preoperative evaluation consists of anamnesis, physical examination, and laboratory tests. An electrocardiogram and echocardiogram will be performed to assess the participants' cardiac function. A computed tomography (CT) scan of the chest will also be performed to obtain the Haller index, as well as an analysis of lung volumes and thoracoabdominal kinematics and diaphragmatic mobility.

Participants will also answer the quality of life questionnaires that will be repeated postoperatively.

Participants will undergo minimally invasive repair of pectus excavatum (MIRPE) with one or two metal bars according to randomization.

In the postoperative period, the displacement of the metal bars will be evaluated through chest X-ray and pain scale evaluation.

Conditions

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Funnel Chest

Keywords

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Funnel chest Quality of life Video-assisted thoracic surgery Prostheses and implants.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One bar

MIRPE utilizing just one metallic bar

Group Type ACTIVE_COMPARATOR

MIRPE with one bar

Intervention Type PROCEDURE

Minimally invasive repair of pectus excavatum utilizing one metallic bar

Two bars

MIRPE utilizing two metallic bars fixed with the bridge device

Group Type ACTIVE_COMPARATOR

MIRPE with two bars

Intervention Type PROCEDURE

Minimally invasive repair of pectus excavatum utilizing two metallic bars

Interventions

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MIRPE with two bars

Minimally invasive repair of pectus excavatum utilizing two metallic bars

Intervention Type PROCEDURE

MIRPE with one bar

Minimally invasive repair of pectus excavatum utilizing one metallic bar

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Participants over 12 years of age;
* Pectus excavatum;
* Haller index \> 3.25

Exclusion Criteria

* Associated congenital anomalies;
* Unable to answer the quality of life questionnaires;
* Congenital heart disease;
* Chronic immunosuppression.
* Previous chest surgery or pleural drainage
* Associated coagulopathies and/or use of anticoagulant medications
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Alemão Oswaldo Cruz

OTHER

Sponsor Role collaborator

Traumec Tecnologia e Implantes Ortopedicos Ltda

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Miguel L. Tedde

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel L Tedde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor) FMUSP

Paulo M Pego-Fernandes, MD, PhD

Role: STUDY_DIRECTOR

Heart Institute (InCor) FMUSP

Locations

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Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Gustavo F Guilherme, MD

Role: CONTACT

Phone: +55 11 2661-5000

Email: [email protected]

Facility Contacts

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Miguel L Tedde, MD, PhD

Role: primary

References

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de Carvalho RLC, Tedde ML, de Campos JRM, Hamilton NN, Guilherme GF, Sousa VM, Junior VFS, Savazzi FH, Pego-Fernandes PM. Quality of life outcomes after minimally invasive repair of pectus excavatum utilizing a new set of metallic bars and stabilizers. J Pediatr Surg. 2021 Mar;56(3):545-549. doi: 10.1016/j.jpedsurg.2020.06.036. Epub 2020 Jun 30.

Reference Type BACKGROUND
PMID: 32711943 (View on PubMed)

Tedde ML, Togoro SY, Eisinger RS, Okumura EM, Fernandes A, Pego-Fernandes PM, Campos JRM. Back to the future: a case series of minimally invasive repair of pectus excavatum with regular instruments. J Bras Pneumol. 2019 Feb 11;45(1):e20170373. doi: 10.1590/1806-3713/e20170373.

Reference Type BACKGROUND
PMID: 30758428 (View on PubMed)

Togoro SY, Tedde ML, Eisinger RS, Okumura EM, de Campos JRM, Pego-Fernandes PM. The Vacuum Bell device as a sternal lifter: An immediate effect even with a short time use. J Pediatr Surg. 2018 Mar;53(3):406-410. doi: 10.1016/j.jpedsurg.2017.04.016. Epub 2017 May 1.

Reference Type BACKGROUND
PMID: 28495420 (View on PubMed)

de Campos JR, Tedde ML. Management of deep pectus excavatum (DPE). Ann Cardiothorac Surg. 2016 Sep;5(5):476-484. doi: 10.21037/acs.2016.09.02.

Reference Type BACKGROUND
PMID: 27747181 (View on PubMed)

Tedde ML, de Campos JR, Wihlm JM, Jatene FB. The Nuss procedure made safer: an effective and simple sternal elevation manoeuvre. Eur J Cardiothorac Surg. 2012 Nov;42(5):890-1. doi: 10.1093/ejcts/ezs442. Epub 2012 Jul 24.

Reference Type BACKGROUND
PMID: 22833539 (View on PubMed)

Tedde ML, Campos JR, Das-Neves-Pereira JC, Abrao FC, Jatene FB. The search for stability: bar displacement in three series of pectus excavatum patients treated with the Nuss technique. Clinics (Sao Paulo). 2011;66(10):1743-6. doi: 10.1590/s1807-59322011001000012.

Reference Type BACKGROUND
PMID: 22012046 (View on PubMed)

Other Identifiers

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29724420.1.0000.0068

Identifier Type: -

Identifier Source: org_study_id