An interventional study of MIRPE with two bars and MIRPE with one bar in Funnel Chest, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MIRPE utilizing just one metallic bar
Procedure: MIRPE with one bar
MIRPE utilizing two metallic bars fixed with the bridge device
Procedure: MIRPE with two bars
Minimally invasive repair of pectus excavatum utilizing two metallic bars
Minimally invasive repair of pectus excavatum utilizing one metallic bar
Thoracoabdominal kinematics and lung volumes
Measurement of lung volumes in liters (L) will be obtained indirectly through optoelectronic plethysmography.
Time frame: 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.
Time frame: Change from baseline to 180 days.
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.
Time frame: Pre op and 180 days
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).
Time frame: Change from baseline to 180 days
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.
Time frame: Preoperative period and 180 days
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.
Time frame: Preoperative period and 180 days
Plan to share: No
Started Oct 2021 (actual). Primary completion is estimated for Oct 2022, 12 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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