Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers
The aim of this monocentric, prospective, non randomised study with 25 healthy volunteers is to assess anorectal function ( i.e rectal compliance and sensory thresholds) in health with a short protocol barostat versus conventional procedures (i.e. standard barostat protocol and high resolution anorectal manometry). Anorectal dysfunction is a key mechanism in the development of fecal incontinence and symptoms of obstructive defecation.
In this study volunteers will be examined - after explanation, physical examination and verification of in- and exclusion criteria - by anorectal barostat with short and standard protocol as well as by proctoscopy and endoanal ultrasound.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers|
- Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers [ Time Frame: during hospital stay, estmated 0.5 days ] [ Designated as safety issue: No ]
- anorectal perception thresholds in % in relation to rectal capacity assessed in ml [ Time Frame: at time of hospital stay approx 0.5 days ] [ Designated as safety issue: No ]
Comparison of anorectal perception thresholds and rectal capacity with the simplified barostat protocol with:
- the anorectal perception thresholds and rectal capacity in accordance with the standard protocol
- the pressure of the anal sphincter and the length at rest and during voluntary contraction,
- the length and the morphological integrity of the anal sphincter detected by ultrasound
|Study Start Date:||January 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Device: anorectal manometry
For a coordinated anorectal function in addition to the anal sphincter the perception of rectal distension (visceral perception) and elasticity / compliance of the anorectum and stool consistency is important. A disturbed anorectal function may lead to functional defecation disorders or incontinence.
The currently available methods for measuring physiological assessment of anorectal function mostly focus on measurement of sphincter pressures, but generally provide no complete explanation for the underlying pathophysiology of defecation disorders. By voluntary contraction of the striated muscles of the external anal sphincter and puborectalis muscle defecation can be further delayed. In addition, however, other continence mechanisms play an important role.
The Group for the Study of functional gastrointestinal disorders at the Clinic for Gastroenterology at the University Hospital of Zurich has a great expertise in the establishment of new research methods such as the already in routine clinical practice used high-resolution anorectal manometry and has conducted numerous studies with anorectal Barostat. To use the results of Barostat also in everyday clinical practice in patients with defecation disorders this technique means significant simplification of the instrumental methodology and shortening of the work described in the literature. Before the simplified barostat can be used with the shortened protocol in different patient groups and clinical practice, it generally requires the validation of the technique in healthy subjects to define the range of normal values.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456442
|University Hospital Zurich, Gastroenterology and Hepatology|
|Zurich, Switzerland, 8091|
|Study Director:||01 Studienregister MasterAdmins||UniversitaetsSpital Zuerich|
|Principal Investigator:||Heiko Fruehauf, MD||University Hospital Zurich, Division of Gastroenterology and Hepatology|