Clinical trial NCT05124626: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Funnel Chest
Keywords: Funnel chest
Quality of life
Video-assisted thoracic surgery
Prostheses and implants.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Hospital Alemão Oswaldo Cruz
name: Traumec Tecnologia e Implantes Ortopedicos Ltda
First posted: 2021-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Thoracoabdominal kinematics and lung volumes
timeFrame: Change from baseline to 180 days
measure: Metallic bars displacement
timeFrame: Change from baseline to 180 days.
Secondary outcomes:
measure: Diaphragmatic mobility
timeFrame: Pre op and 180 days
measure: Pain intensity
timeFrame: Change from baseline to 180 days
measure: Quality of life related to physical and mental health
timeFrame: Preoperative period and 180 days
measure: Physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum
timeFrame: Preoperative period and 180 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
Study officials:
affiliation: Heart Institute (InCor) FMUSP
name: Miguel L Tedde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute (InCor) FMUSP
name: Paulo M Pego-Fernandes, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.