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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01300884
Study type Observational
Source Augusta University
Contact
Status Completed
Phase
Start date February 2008
Completion date December 2011

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