- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05124626
Evaluation of Chest Wall Motility After MIRPE
Chest Wall Motility in Pectus Excavatum Patients Before and After MIRPE Performed With One or Two Metallic Bars: a Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gustavo F Guilherme, MD
- Phone Number: 5708 +55 11 2661-5000
- Email: contatogustavofalavigna@gmail.com
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil
- Recruiting
- Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
-
Contact:
- Miguel L Tedde, MD, PhD
- Phone Number: 5708 26615000
- Email: tedde@usp.br
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Principal Investigator:
- Miguel L Tedde, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: One bar
MIRPE utilizing just one metallic bar
|
Minimally invasive repair of pectus excavatum utilizing one metallic bar
|
Active Comparator: Two bars
MIRPE utilizing two metallic bars fixed with the bridge device
|
Minimally invasive repair of pectus excavatum utilizing two metallic bars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thoracoabdominal kinematics and lung volumes
Time Frame: Change from baseline to 180 days
|
Measurement of lung volumes in liters (L) will be obtained indirectly through optoelectronic plethysmography.
|
Change from baseline to 180 days
|
Metallic bars displacement
Time Frame: Change from baseline to 180 days.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragmatic mobility
Time Frame: Pre op and 180 days
|
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.
|
Pre op and 180 days
|
Pain intensity
Time Frame: Change from baseline to 180 days
|
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).
|
Change from baseline to 180 days
|
Quality of life related to physical and mental health
Time Frame: Preoperative period and 180 days
|
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.
|
Preoperative period and 180 days
|
Physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum
Time Frame: Preoperative period and 180 days
|
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.
|
Preoperative period and 180 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miguel L Tedde, MD, PhD, Heart Institute (InCor) FMUSP
- Study Director: Paulo M Pego-Fernandes, MD, PhD, Heart Institute (InCor) FMUSP
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29724420.1.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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