Sierra High Definition Ano-Rectal Manometry
Completed
Conditions studied: Constipation, Fecal Incontinence
In brief
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.
Key facts
- Study ID
- NCT01300884
- Run by
- Augusta University
- People needed
- 80
- Starts
- 2008-02-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2018-07-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For patients:
- 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)
- Adults between the ages of 18-80 yrs.
- For healthy volunteers:
- Adults between the ages of 18-80 yrs
- No gastrointestinal symptoms
You may not qualify if…
- Rectal prolapse or anal fissure on physical examination
- Recent pelvic or recto-anal surgery (< 6 months ago)
- History of pelvic irradiation.
Where it is running
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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