Healthy Clinical Trial - Short Protocol Barostat for Assessment of

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT01456442
Study type	Interventional
Source	University of Zurich
Contact
Status	Completed
Phase	Phase 4
Start date	January 2011
Completion date	November 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms