跳至主要内容
临床试验/NCT02633592
NCT02633592已完成不适用

Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry: a Randomized Comparison of Measurements in the Seated and Left Lateral Positions

University of Zurich2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Recto-anal pressure gradient (RAPG)

研究概览

简要总结

To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more naturalistic / physiological upright, seated position on a commode provides a more valid assessment of anorectal function and simulated defecation than the same test performed in the standard, left lateral position

详细描述

High Resolution Anorectal Manometry (HR-ARM) with data presented as pressure topography is a recent addition to the tests available for diagnosis of defecatory disorders including fecal incontinence and constipation.HR-ARM represents an advance on conventional manometry because closely spaced sensors across the anal sphincter remove the need for a pull-through procedure and facilitate data acquisition and interpretation. In particular measurements are not confounded by changes in position of the catheter relative to anal sphincter that occur during voluntary contraction and, especially, simulated defecation.

Notwithstanding these technological improvements, important concerns remain about the validity of manometry measurements during simulated defecation. These concerns are based on the observation in both conventional and HR-ARM that a large proportion of healthy individuals appear to have abnormal anorectal function ("dyssynergia") during simulated defecation.This limitation led to the recommendation that the finding of dyssynergia on manometry should be confirmed by defecography. This is unsatisfactory as diagnostic tests should not have a high rate of "false positives" and also because this increases the time and costs needed to complete diagnostic investigation in patients with defecatory disorders.

The high rate of abnormal findings in healthy individuals may be because current manometry procedures and other anorectal tests (e.g. rectal balloon expulsion) are usually performed, not in the upright, seated position (USP) usually adopted for defecation, but in the un-physiological left lateral position (LLP). Several factors may contribute. First, defecation in the LLP is not aided by gravity as it is in the sitting position. Second, anorectal anatomy may be altered and less conducive to the passage of stool in the LLP. Third, simulating defecation in the LLP does not reflect normal behavior and, despite optimal interaction and explanation by the investigator, changes in patient behavior may result in apparent "dyssynergia" Finally, social stress, related to proximity of the investigator observing defecation, makes individuals feel unable to strain at stool or attempt defecation.

A simple probe holder device that, by adhering to the skin is positioned at the natal cleft to support the ManoScan HR ARM catheter can be used to assess anorectal pressures in the sitting position (both produced by Given Imaging, Yoqeam, Israel). This simple device stabilizes the catheter position when the patient is in USP on a commode and allows the investigator to withdraw behind the curtains of the examination cubicle.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria: All
  • Signed informed consent
  • Male or female, age 18 - 75 years
  • Females eligible to participate either if physiologically incapable of becoming pregnant or with a negative urine pregnancy test at screening
  • HS: Absence of symptoms of constipation or incontinence
  • Patients with fecal incontinence
  • Passive or Urge Incontinence
  • Wexner Score of 5-20 ("more than mild severity of incontinence")
  • Patients with obstructive defecation
  • Cleveland Clinic Constipation Scoring System: 10-30 ("more than mild severity of constipation)

排除标准

  • • Participation in any other clinical trial with investigational or approved drugs within the last month before the study
  • Significant medical, surgical or psychiatric disease requiring on-going active management
  • Previous gastrointestinal or gynaecological disease (exception: non symptomatic ovarian cysts, occasional reflux, appendectomy, hysterectomy, cholecystectomy)
  • Regular use of opiates or other constipating agents
  • Presence of fecal impaction on clinical per rectal exam
  • Abnormal findings on proctoscopy / endoscopy (e.g. Inflammatory Bowel Disease, neoplasm, acute or chronic anal fissure, large haemorrhoids (grade 3-4) intussusception, prolapse or gross perineal descent (>5cm) on straining
  • Insufficient understanding of German language to comply with instructions
  • Contraindication for MRI: Presence of non-MR-compatible metallic implants, devices or metallic foreign bodies

研究组 & 干预措施

HRARM

Active Comparator

Patients and healthy volunteers are subjected to position change ( LLP to SP) during pressure measurements with HR-ARM.

干预措施: HRARM (Other)

MRI Defecography

Active Comparator

Patients and healthy volunteers are subjected to position change during MRI Defecography

干预措施: MRI Defecography (Other)

结局指标

主要结局

Recto-anal pressure gradient (RAPG)

时间窗: 1 hour

RAPG change in the LLP and sitting position (mmHg)

次要结局

  • Presence of dyssynergia on HR-ARM(1 hour)
  • Presence of dyssynergic defecation on MRI in healthy controls(1 hour)
  • Agreement of MR findings in different body positions with HR-ARM findings(1 hour)
  • Patient positional preference(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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