Sierra High Definition Ano-Rectal Manometry

Augusta University

Status: Completed

Conditions: Fecal Incontinence; Constipation

Study type: Observational

Funder types: Other

Identifiers

NCT01300884

200705716

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 3 patient groups

healthy volunteers

patients with fecal incontinence

patients with constipation