NCT05124626

Evaluation of Chest Wall Motility After MIRPE

Status unknown NA Last updated 18 November 2021

What this trial tests

NA trial testing MIRPE with two bars in Funnel Chest in 20 participants. Status unknown.

Timeline

1 October 2021

Primary endpoint
30 October 2022

1 December 2022

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 October 2021
Primary completion	30 October 2022
Estimated completion	1 December 2022
Sites	1 location across Brazil

Drugs / interventions tested

• MIRPE with two bars
• MIRPE with one bar

Conditions studied

• Funnel Chest — all drugs for Funnel Chest →

Sponsor

University of Sao Paulo

Who can join

12 and older, any sex, with Funnel Chest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.