Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2008-02-29
2011-12-31
Brief Summary
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Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation will be recruited. Because anorectal disorders are more common in women, the investigators will recruit approximately 8 men and 12 women in each group. Each subject will undergo anorectal manometry, anal ultrasound and high definition manometry.
Data Analysis: Spearman correlational analysis will be performed to compare the parameters listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying anatomic sphincter defects will be assessed.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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healthy volunteers
No interventions assigned to this group
patients with fecal incontinence
No interventions assigned to this group
patients with constipation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Either fecal incontinence (the occurrence of at least one episode of involuntary discharge of stool matter per week) or constipation (Rome III criteria) (16,17)
2. Adults between the ages of 18-80 yrs.
For healthy volunteers:
1. Adults between the ages of 18-80 yrs
2. No gastrointestinal symptoms
Exclusion Criteria
2. Recent pelvic or recto-anal surgery (\< 6 months ago)
3. History of pelvic irradiation.
18 Years
80 Years
ALL
Yes
Sponsors
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Augusta University
OTHER
Responsible Party
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Satish Rao
Professor
Principal Investigators
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Satish SC Rao, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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Other Identifiers
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200705716
Identifier Type: -
Identifier Source: org_study_id
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