View Clinical Trial (Medical Research Study)
Sierra High Definition Ano-Rectal Manometry
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Constipation - Fecal Incontinence |
| Purpose: |
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Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately
characterizes anorectal anatomy and function in healthy humans; HDM provides comparable
information regarding the structure and function of the anorectal region, to that obtained
from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal
incontinence or constipation.
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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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
For patients:
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:
1. Rectal prolapse or anal fissure on physical examination
2. Recent pelvic or recto-anal surgery (< 6 months ago)
3. History of pelvic irradiation.
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| NCT ID: |
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NCT01300884 |
| Primary Contact: |
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Principal Investigator
Satish SC Rao, MD, Phd
University of Iowa
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| Backup Contact: |
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N/A |
| Location Contact: |
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Iowa City, Iowa 52242
United States
Satish SC Rao, MD, PhD
Phone: 319-353-6602
Email: satish-rao@uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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