Clinical Trial: Mechano-Physiological Approach to Anorectal Function
This study is not yet open for patient recruitment.
Verified by Penn State University September 2005
| Sponsors and Collaborators: | Penn State University American College of Gastroenterology | | Information provided by: | Penn State University | | ClinicalTrials.gov Identifier: | NCT00219518 | |
Purpose
We hypothesize that defecatory disorders can be described in mechanical terms which would allow a mechanistic description of disorders which would in turn allow better directed
biofeedback mechanisms to treat disorders of defecation.
| Condition | Intervention |
Constipation
| Procedure: defecography
|
MedlinePlus related topics: Constipation
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: Mechano-Physiological Approach to Normal Anorectal Function and the Classification of Defecatory Disorders
Further Study Details:
Expected Total Enrollment: 30
Disorders of defecation are very common and the process of defecation remains poorly described. This results in a limited approach to treatment of patients, with limited success. This study will simultaneously measure multiple components of the process of defecation - the
abdominal wall and perineal muscle activity, the pressure within the
rectum and in the
anal canal and the change in shape of the anorectal region of the colon, in order to develop a biomechanical model which can describe the normal and
abnormal defecatory process. It is anticipated that, by understanding the process in these terms will allow a new approach to categorizing and describing defecation problems which in turn will lead to more specific approaches of treatment which will be tailored to individual patients. These parameters will compared in volunteers with no defecatory disorders and patients with defecatory disorders who are being referred for defecography as part of their
clinical evaluation.
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Controls
Inclusion Criteria:
- Women
- No defecatory problems
- On no medication which affect bowel habits
Exclusion Criteria:
Patients
Inclusion Criteria:
- Difficulty in defecation
- Women
Exclusion criteria:
- Pregnancy
- Medication which can affect bowel movement
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00219518
Ann Ouyang, MD 717-531-8741 aouyang@psu.edu
Helena F Wrzos, MD,PhD 717-531-5125 hwrzos@psu.edu
Pennsylvania Hershey Medical Center, Hershey, Pennsylvania, 17033, United States
kathyrn Kaylor 717-531-8495 kkaylor@psu.edu
David Hartman, MD, Sub-Investigator
Study chairs or principal investigators
Ann Ouyang, MD, Principal Investigator, Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
More Information
Study ID Numbers: HY03-368
Last Updated: September 21, 2005
Record first received: September 14, 2005
ClinicalTrials.gov Identifier: NCT00219518
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-27
Source: ClinicalTrials.gov
Cache Date: September 28, 2005