Sierra High Definition Ano-Rectal Manometry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01300884
First received: January 19, 2011
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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
Constipation
Fecal Incontinence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation [ Time Frame: One visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy volunteers
patients with fecal incontinence
patients with constipation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300884

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Satish SC Rao, MD, PhD    319-353-6602    satish-rao@uiowa.edu   
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Satish SC Rao, MD, Phd University of Iowa
  More Information

No publications provided

Responsible Party: Satish SC Rao/Professor of Internal Medicine and Director of Neurogastroenterology and GI Motility, University of Iowa
ClinicalTrials.gov Identifier: NCT01300884     History of Changes
Other Study ID Numbers: 200705716
Study First Received: January 19, 2011
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constipation
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 01, 2014