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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: anorectal manometry; Device: barostat

Detailed 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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich, Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Healthy men and women between 18 and 65 years of age without gastrointestinal disease needing medical or surgical treatment.
• No medication (with the exception of occasional intake of paracetamol)
• Availability of all investigations (high resolution anorectal manometry, anorectal barostat with short and standard protocol, proctoscopy and endoanal ultrasound to assess sphincter morphology)
• Good communication with study doctor and meeting of all study requirements.
• Written consent after detailed explanation of study.

Exclusion criteria:

• Gastrointestinal symptoms especially fecal incontinence and obstructed defecation
• Structural or functional changes of upper and lower GI Tract (i.e gastric ulcer, malignancy , symptoms of IBS)
• Symptomatic or manometrically diagnosed motility disorders of the upper and lower GI tract for example anismus
• Surgery or interventions in the lower and upper GI tract (appendectomy and hernia excluded) included congenital malformations
• Pelvic radiation therapy
• Fecal incontinence, defined as involuntary loss of liquid or hard stool
• Functional defecation disorders as defined by the ROME III criteria.
• Pregnancy with history of vaginal delivery.
• Acute or chronic disease ( for example IBD)
• Malignancy
• Intake of medication one week prior to study begin. Anticoagulants and medication influencing GI motility like prokinetics, calcium channel blockers and antibiotics
• Drug or alcohol use
• Pregnancy and lactation
• Women at reproductive age will receive pregnancy testing before inclusion into study.
• Physical, mental , neurological or psychiatric conditions limiting ability to meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers	during hospital stay, estmated 0.5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anorectal perception thresholds in % in relation to rectal capacity assessed in ml	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	at time of hospital stay approx 0.5 days

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Heiko Fruehauf, MD, University Hospital Zurich, Division of Gastroenterology and Hepatology

Publications and helpful links

General Publications

• Sauter M, Heinrich H, Fox M, Misselwitz B, Halama M, Schwizer W, Fried M, Fruehauf H. Toward more accurate measurements of anorectal motor and sensory function in routine clinical practice: validation of high-resolution anorectal manometry and Rapid Barostat Bag measurements of rectal function. Neurogastroenterol Motil. 2014 May;26(5):685-95. doi: 10.1111/nmo.12317. Epub 2014 Feb 12.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: KEK-ZH-Nr. 2010-0330