Sierra High Definition Ano-Rectal Manometry

NCT01300884 | Completed

• 1 other identifier: 200705716
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

healthy volunteers

patients with fecal incontinence

patients with constipation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Constipation; Fecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Satish SC Rao, MD, Phd

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

US (1)