Sierra High Definition Ano-Rectal Manometry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01300884

Enrollment

Registered

2011-02-23

Start date

2008-02-29

Completion date

2011-12-31

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Fecal Incontinence

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results