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Evaluation of Chest Wall Motility After MIRPE

Primary Purpose

Funnel Chest

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MIRPE with two bars
MIRPE with one bar
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Funnel Chest focused on measuring Funnel chest, Quality of life, Video-assisted thoracic surgery, Prostheses and implants.

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

One bar

Two bars

Arm Description

MIRPE utilizing just one metallic bar

MIRPE utilizing two metallic bars fixed with the bridge device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diaphragmatic mobility
Measurement of the craniocaudal displacement of the left branch of the portal vein in millimeters (mm) by ultrasonographic examination as a measure of diaphragmatic mobility.
Pain intensity
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Quality of life related to physical and mental health
The Short-Form-36 Health Survey (SF-36) is a multidimensional instrument to assess health-related quality of life. It comprises two summary subscales: (1) the physical component summary features aspects of 'physical functioning', 'physical role functioning', 'bodily pain', and 'health in general' and (2) the mental component summary is based on the dimensions 'social functioning', 'emotional role functioning', 'vitality', and 'mental health'. Higher scores are indicative of better health.
Physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum
The Pectus Excavatum Evaluation Questionnaire (PEEQ) consists of 12 questions for patients which result can vary from 21 to 40; and with 13 questions for their parents which result can vary from 13 to 52 with bigger numbers representing better quality of life.

Full Information

First Posted
October 5, 2021
Last Updated
November 5, 2021
Sponsor
University of Sao Paulo
Collaborators
Hospital Alemão Oswaldo Cruz, Traumec Tecnologia e Implantes Ortopedicos Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT05124626
Brief Title
Evaluation of Chest Wall Motility After MIRPE
Official Title
Chest Wall Motility in Pectus Excavatum Patients Before and After MIRPE Performed With One or Two Metallic Bars: a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Hospital Alemão Oswaldo Cruz, Traumec Tecnologia e Implantes Ortopedicos Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Funnel Chest
Keywords
Funnel chest, Quality of life, Video-assisted thoracic surgery, Prostheses and implants.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One bar
Arm Type
Active Comparator
Arm Description
MIRPE utilizing just one metallic bar
Arm Title
Two bars
Arm Type
Active Comparator
Arm Description
MIRPE utilizing two metallic bars fixed with the bridge device
Intervention Type
Procedure
Intervention Name(s)
MIRPE with two bars
Intervention Description
Minimally invasive repair of pectus excavatum utilizing two metallic bars
Intervention Type
Procedure
Intervention Name(s)
MIRPE with one bar
Intervention Description
Minimally invasive repair of pectus excavatum utilizing one metallic bar
Primary Outcome Measure Information:
Title
Thoracoabdominal kinematics and lung volumes
Description
Measurement of lung volumes in liters (L) will be obtained indirectly through optoelectronic plethysmography.
Time Frame
Change from baseline to 180 days
Title
Metallic bars displacement
Description
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.
Time Frame
Change from baseline to 180 days.
Secondary Outcome Measure Information:
Title
Diaphragmatic mobility
Description
Measurement of the craniocaudal displacement of the left branch of the portal vein in millimeters (mm) by ultrasonographic examination as a measure of diaphragmatic mobility.
Time Frame
Pre op and 180 days
Title
Pain intensity
Description
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
Change from baseline to 180 days
Title
Quality of life related to physical and mental health
Description
The Short-Form-36 Health Survey (SF-36) is a multidimensional instrument to assess health-related quality of life. It comprises two summary subscales: (1) the physical component summary features aspects of 'physical functioning', 'physical role functioning', 'bodily pain', and 'health in general' and (2) the mental component summary is based on the dimensions 'social functioning', 'emotional role functioning', 'vitality', and 'mental health'. Higher scores are indicative of better health.
Time Frame
Preoperative period and 180 days
Title
Physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum
Description
The Pectus Excavatum Evaluation Questionnaire (PEEQ) consists of 12 questions for patients which result can vary from 21 to 40; and with 13 questions for their parents which result can vary from 13 to 52 with bigger numbers representing better quality of life.
Time Frame
Preoperative period and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo F Guilherme, MD
Phone
+55 11 2661-5000
Ext
5708
Email
contatogustavofalavigna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel L Tedde, MD, PhD
Organizational Affiliation
Heart Institute (InCor) FMUSP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo M Pego-Fernandes, MD, PhD
Organizational Affiliation
Heart Institute (InCor) FMUSP
Official's Role
Study Director
Facility Information:
Facility Name
Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel L Tedde, MD, PhD
Phone
26615000
Ext
5708
Email
tedde@usp.br
First Name & Middle Initial & Last Name & Degree
Miguel L Tedde, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32711943
Citation
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.
Results Reference
background
PubMed Identifier
30758428
Citation
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.
Results Reference
background
PubMed Identifier
28495420
Citation
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.
Results Reference
background
PubMed Identifier
27747181
Citation
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.
Results Reference
background
PubMed Identifier
22833539
Citation
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.
Results Reference
background
PubMed Identifier
22012046
Citation
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.
Results Reference
background

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Evaluation of Chest Wall Motility After MIRPE

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