Sierra High Definition Ano-Rectal Manometry
Recruitment status was: Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
- To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation [ Time Frame: One visit ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|patients with fecal incontinence|
|patients with constipation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300884
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Satish SC Rao, MD, Phd||University of Iowa|