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临床试验/NCT02263170
NCT02263170已完成不适用

Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Sphincter morphology

研究概览

简要总结

With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary consortium consisting of representatives ranging from clinical medicine via microelectronics towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The aim of this campaign includes development of implantable prototype devices acting as artificial continence muscles using low-voltage electrically activated polymers (EAPs) controlled by implemented pressure sensors and the patient.

Subsequently, the knowledge of the anatomical and biomechanical properties of the anal sphincter complex are of cardinal importance. Most of the existing data on anatomy and physiology results is based on old studies and almost no data on biomechanical properties are available. However, new technologies or even merging data from different examination methods might provide new information in this field.

详细描述

Background

Fecal incontinence (FI) is affecting self-confidence and can lead to social isolation and even loss of employment Often conservative treatment as the first option is ineffective and surgical interventions follow conservative are necessary.

Small defects of the anal sphincter muscles might be treated with sphincter repair and sacral neuromodulation (SNM) However, patients rarely become fully continent or short-term results deteriorate in the long term [1]. Those patients and patients with large defects are candidates for a neosphincter procedure (artificial bowel sphincter or graciloplasty). However, the success rate of these methods is limited and the explantation rate is high. A permanent colostomy associated with massive psychosocial impairment remains as ultimate treatment option With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary consortium consisting of representatives ranging from clinical medicine via microelectronics towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The aim of this campaign includes development of implantable prototype devices acting as artificial continence muscles using low-voltage electrically activated polymers (EAPs) controlled by implemented pressure sensors and the patient.

Subsequently, the knowledge of the anatomical and biomechanical properties of the anal sphincter complex are of cardinal importance. Most of the existing data on anatomy and physiology results is based on old studies and almost no data on biomechanical properties are available. However, new technologies or even merging data from different examination methods might provide new information in this field.

Accurate imaging data on the pelvic floor region is crucial for the development of a new, implantable device for restoration of fecal continence. Optimal size (inner, outer diameter, length) and geometrical shape (cylinder, cone, torus) adapted to different functional states (rest, squeezing, defecation) will improve function and prevent erosion and consequent infection of such a prosthesis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed Consent as documented by signature
  • Absence of ano-rectal or pelvic floor symptoms (patient history, Wexner score and Longo's obstructed defecation syndrome (ODS) score =
  • Appendix Constipation and Faecal Incontinence Score form)
  • MRI safety (no metallic implants. Appendix MRI safety form)
  • Normal weighted (20<BMI<30)
  • Age ≥ 60 years
  • Exclusion Criteria
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • age (<18 years old)
  • history of complicated child delivery
  • previous anorectal surgery

排除标准

  • 未提供

结局指标

主要结局

Sphincter morphology

时间窗: At baseline

Functional sphincter variables are: anal canal length, resting, squeeze, and relaxation pressures, squeeze time, anal pressure in response to coughing, RAIR (percentage of anal relaxation), rectal volume filling to first sensation, urge and maximal tolerable volume, and distension of the anal canal in response to different filling volumes. Anatomical parameters are: distinction between internal and external sphincter (yes/no), sphincter lengths, sphincter thickness, and sphincter volumes.

次要结局

  • Test feasibility of merging 3D US data and MR images(At baseline)
  • Test feasibility of FLIP in measuring the biomechanical properties of the anal canal(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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