Sierra High Definition Ano-Rectal Manometry



Status:Completed
Conditions:Constipation, Gastrointestinal, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:7/25/2018
Start Date:February 2008
End Date:December 2011

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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.


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.
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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