Sierra High Definition Ano-Rectal Manometry

Constipation Clinical Trial

Official title:

Sierra High Definition Ano-Rectal Manometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300884
• Other study ID #: 200705716
• Status: Completed
• Start date: February 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2018
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation		One visit