Defecation mechanisms and subtyping of constipation patients with Fecobionics

Fecobionics对便秘患者的排便机制和分型

• 批准号: 10418687
• 负责人: Hans Gregersen
• 金额: $ 64.55万
• 依托单位: CALIFORNIA MEDICAL INNOVATIONS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10418687
• 关键词: Affect; Anal canal; Anus; Area; Barium; Biomechanics; Chronic; Circular layer of muscularis propria of anal canal; Colorectal; Conflict (Psychology); Constipation; Data; Defecation; Defecography; Defect; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Etiology; Event; Expenditure; External anal sphincter structure; Feces; Friction; Functional disorder; Future; Geometry; Goals; Health; Health Care Costs; Human; Incidence; Innovative Therapy; Intra-abdominal; Knowledge; Laboratories; Lead; Length; Location; Manometry; Maps; Medicine; Methods; Modality; Motor; Muscle; North America; Patients; Pattern; Pelvic Floor Muscle; Peristalsis; Persons; Physiological; Physiology; Play; Population; Privatization; Process; Property; Radiation; Records; Rectum; Reflex action; Relaxation; Research; Resolution; Risk; Role; Sensory; Shapes; Skeletal Muscle; Smooth Muscle; Sphincter; Stress; Symptoms; System; Test Result; Testing; Therapeutic; Thinking; Time; Treatment outcome; Valsalva Maneuver; abdominal pressure; abdominal wall; anorectal disorder; biomechanical model; cell motility; clinical decision-making; cost; driving force; improved; insight; laxative; mathematical model; motility disorder; novel; outcome prediction; pressure; rectal; sphincter ani muscle structure; symptom treatment; tool; treatment strategy; vector; viscoelasticity; wireless

ABSTRACT Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America with rising incidence that poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. The significant problems are, 1) incomplete understanding of the defecation reflex and 2) lack of physiologically relevant and practical diagnostic test for identifying the underlying mechanism(s). Current diagnostic tests provide incomplete and often conflicting information. Not surprisingly, results of these tests correlate poorly with symptoms and treatment outcomes. Our objective is to provide an improved understanding of the continence mechanisms and defecation patterns in healthy subjects and patients with CC using a novel Fecobionics device for mapping the geometric and manometric profiles during evacuation. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, shape, and viscoelastic properties of the rectum and anal canal simultaneously. Our central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. Fecobionics can provide complete picture of the normal defecation pattern (“signatures”) that includes rectal peristaltic reflex, deformability of the device and distensibility of the anal sphincters in healthy subjects and patients with various subtypes of CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. We will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. We will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. Our proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex/process in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.

抽象的 慢性便秘 (CC) 是一种常见疾病，影响北美多达 25% 的人口 发病率的上升给医疗费用带来了重大负担。这种情况的病理生理学是。 人们对此知之甚少，因此治疗措施不充分，主要问题是：1) 对排便反射的理解不完全；2）缺乏生理相关性和实用性 用于识别潜在机制的诊断测试当前的诊断测试提供不完整且不完整的信息。 毫不奇怪，这些测试的结果与症状和症状的相关性很差。 我们的目标是更好地了解节制机制。 使用新型 Fecobionics 设备进行绘图，了解健康受试者和 CC 患者的排便模式 Fecobionics 是一种电子模拟凳子，具有疏散过程中的几何和测压轮廓。 正常粪便的稠度和形状 该设备记录压力、横截面积、方向、 直肠和肛管的弯曲、形状和粘弹性特性同时发生。 假设是直肠蠕动是排便反射的关键组成部分，但在本研究中并未对其进行评估。 新型 Fecobionics 设备将模仿自然排便和当前的诊断测试范例。 为肛门直肠生理学和病理生理学提供新的机制见解，以促进 开发新的 CC 治疗方法可以提供正常排便的完整情况。 模式（“特征”），包括直肠蠕动反射、装置的可变形性和 健康受试者和患有各种 CC 亚型的患者的肛门括约肌的具体目标如下。 如下： 1) 使用 Fecobionics 研究正常对照受试者的排便动态。 直肠收缩/蠕动在正常排便过程中的作用 2) 定义排便模式。 对于伴有排便障碍的 CC 患者，我们将确定直肠收缩是否异常。 3) 使用 Fecobionics 的肛门直肠通道数学模型来增强 了解正常和异常的排便模式，包括排便的长度-张力特性 我们的建议旨在通过提供凳子来改变当前的 CC 研究。 使用一种新颖的设备来检查排便反射的生理参数，该设备将记录， 直肠和肛管的压力、变形性、生物力学、矢量和地形变化。 所记录的参数将使用无线 Fecobionics 设备进行记录，该设备可以详细检查 健康和疾病中排便反射/过程的机械基础（压力和变形）。 该项目的影响在于它评估了一种新颖、安全、低成本、侵入性较小、低风险、无辐射的设备 它能够更好地理解疏散和节制机制并从而促进 创新疗法的未来发展可以改善诊断和治疗。 治疗方式并减少与肛门直肠疾病相关的医疗费用。