跳至主要内容
临床试验/NCT02774798
NCT02774798已完成不适用

Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年4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
31
试验地点
1
主要终点
Opening Pressure

研究概览

简要总结

Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles.

Rectal intussusception occurs when the rectal wall telescopes into itself distally and is termed prolapse when it protrudes through the anal canal. Not all patients will require surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal incontinence. Currently, the Oxford grading system through radiological testing is used for classifying severity of rectal intussusception and prolapse; however this does not give us sufficient information about the anal sphincter muscles.

The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. In previous studies AAR has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence. Thus far, it has not been studied in patients with rectal intussusception and it is hoped that AAR parameters may provide an indication of when rectal intussusception becomes overt rectal prolapse. This can inform the clinician to guide further management of a group of patients with a condition that can have significant impact on quality of life.

详细描述

This an observational study based on not intervention. Patients are grouped depending on grade of prolapse, and all undergo the routine AAR investigation. Patients are grouped solely on differences in pathology already present and not on any intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adults over 18 years old
  • Have capacity to consent to the study
  • Patients with pelvic floor dysfunction and symptoms of rectal intussusception and rectal prolapse

排除标准

  • Minors under the age of 18 years old
  • Patients who lack capacity to consent
  • Patients without pelvic floor dysfunction or symptoms of rectal intussusception or rectal prolapse

结局指标

主要结局

Opening Pressure

时间窗: at specific time point of measurement up to 1 hour

The pressure (in cmH20) at which the anal canl just begins to open

次要结局

  • Opening Elastance(at specific time point of measurement up to 1 hour)
  • Hysteresis(at specific time point of measurement up to 1 hour)
  • Closing Elastance(at specific time point of measurement up to 1 hour)
  • Squeeze Opening Elastance(at specific time point of measurement up to 1 hour)
  • Closing Pressure(at specific time point of measurement up to 1 hour)
  • Squeeze Opening Pressure(at specific time point of measurement up to 1 hour)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Correlation of Anal Acoustic Reflectometry... | 临床试验