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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 23, 2011
Registry last updated: Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed