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Sierra High Definition Ano-Rectal Manometry

Sponsor
Augusta University (Other)
Overall Status
Completed
CT.gov ID
NCT01300884
Collaborator
(none)
80
Enrollment
1
Location
46
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Sierra High Definition Ano-Rectal Manometry
    Actual Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    healthy volunteers
    patients with fecal incontinence
    patients with constipation

    Outcome Measures

    Primary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Augusta University

    Investigators

    • Principal Investigator: Satish SC Rao, MD, Phd, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Satish Rao, Professor, Augusta University
    ClinicalTrials.gov Identifier:
    NCT01300884
    Other Study ID Numbers:
    • 200705716
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Jul 23, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Fecal Incontinence
    Constipation

    Study Results

    No Results Posted as of Jul 23, 2018