Chest Wall Motility in Pectus Excavatum Patients Before and After MIRPE Performed With One or Two Metallic Bars: a Comparative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Thoracoabdominal kinematics and lung volumes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants over 12 years of age;
- •Pectus excavatum;
- •Haller index > 3.25
排除标准
- •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
结局指标
主要结局
Thoracoabdominal kinematics and lung volumes
时间窗: Change from baseline to 180 days
Measurement of lung volumes in liters (L) will be obtained indirectly through optoelectronic plethysmography.
Metallic bars displacement
时间窗: 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.
次要结局
- Quality of life related to physical and mental health(Preoperative period and 180 days)
- Pain intensity(Change from baseline to 180 days)
- Physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum(Preoperative period and 180 days)
- Diaphragmatic mobility(Pre op and 180 days)
研究者
Miguel L. Tedde
Principal Investigator
University of Sao Paulo