Evaluation of Chest Wall Motility After MIRPE

NCT05124626 | Unknown

• 1 other identifier: 29724420.1.0000.0068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Thoracoabdominal kinematics and lung volumes

  Measurement of lung volumes in liters (L) will be obtained indirectly through optoelectronic plethysmography.

  Change from baseline to 180 days

• Metallic bars displacement

  The displacement of the bars measured in millimeters (mm) in the lateral chest X-ray in the immediate postoperative (d0) and at the end of the period analyzed (dX) considering the distance between the upper point of contact of the bar with the sternum and the most posterior and superior point of the body of the sternum. The bar displacement index is calculated according to the formula: d0 - dX / d0 x 100.

  Change from baseline to 180 days.

Secondary Outcomes (4)

• Diaphragmatic mobility

  Pre op and 180 days

• Pain intensity

  Change from baseline to 180 days

• Quality of life related to physical and mental health

  Preoperative period and 180 days

• Physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum

  Preoperative period and 180 days

Study Arms (2)

One bar

ACTIVE COMPARATOR

MIRPE utilizing just one metallic bar

Procedure: MIRPE with one bar

Two bars

ACTIVE COMPARATOR

MIRPE utilizing two metallic bars fixed with the bridge device

Procedure: MIRPE with two bars

Interventions

MIRPE with two bars PROCEDURE

Minimally invasive repair of pectus excavatum utilizing two metallic bars

Two bars

MIRPE with one bar PROCEDURE

Minimally invasive repair of pectus excavatum utilizing one metallic bar

One bar

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Hospital Alemão Oswaldo Cruz: collaborator
• Traumec Tecnologia e Implantes Ortopedicos Ltda: collaborator

Study Sites (1)

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

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 32711943 BACKGROUND

• 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.

  PMID: 30758428 BACKGROUND

• 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.

  PMID: 28495420 BACKGROUND

• 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.

  PMID: 27747181 BACKGROUND

• 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.

  PMID: 22833539 BACKGROUND

• 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.

  PMID: 22012046 BACKGROUND

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Miguel L Tedde, MD, PhD

  Heart Institute (InCor) FMUSP

  PRINCIPAL INVESTIGATOR

• Paulo M Pego-Fernandes, MD, PhD

  Heart Institute (InCor) FMUSP

  STUDY DIRECTOR

Central Study Contacts

Gustavo F Guilherme, MD

CONTACT

+55 11 2661-5000; contatogustavofalavigna@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 18, 2021
• Study Start: October 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 1, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)