Status:
COMPLETED
Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers
Lead Sponsor:
University of Zurich
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 protoco...
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01456442
Start Date
January 1 2011
End Date
November 1 2012
Last Update
November 14 2012
Active Locations (1)
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1
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, Switzerland, 8091