Constipation Clinical Trial
Official title:
Sierra High Definition Ano-Rectal Manometry
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.
n/a
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