Sierra High Definition Ano-Rectal Manometry
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Constipation Fecal Incontinence |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| healthy volunteers |
| patients with fecal incontinence |
| patients with constipation |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
We will recruit 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation. Because anorectal disorders are more common in women, we will recruit approximately 8 men and 12 women in each group. Because it is possible subjects may sign consent but not participate in the study, or drop out of the study before completion, we will recruit a total of 80 subjects.
Inclusion Criteria:
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
Exclusion Criteria:
- Rectal prolapse or anal fissure on physical examination
- Recent pelvic or recto-anal surgery (< 6 months ago)
- History of pelvic irradiation.
Contacts and Locations| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Satish SC Rao, MD, PhD 319-353-6602 satish-rao@uiowa.edu | |
| Principal Investigator: | Satish SC Rao, MD, Phd | University of Iowa |
More Information
No publications provided
| Responsible Party: | Satish SC Rao/Professor of Internal Medicine and Director of Neurogastroenterology and GI Motility, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01300884 History of Changes |
| Other Study ID Numbers: | 200705716 |
| Study First Received: | January 19, 2011 |
| Last Updated: | March 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Constipation Fecal Incontinence Signs and Symptoms, Digestive Signs and Symptoms |
Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013