Mechano-physiological Approach to Anorectal Function

This study has been terminated.
(inadequate no of constip patients)
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00219518
First received: September 14, 2005
Last updated: June 1, 2011
Last verified: September 2009
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechano-physiological Approach to Normal Anorectal Function and the Classification of Defecatory Disorders

Resource links provided by NLM:


Further study details as provided by Penn State University:

Enrollment: 17
Study Start Date: February 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: defecography
    insertion of catheter to record pressure. Insertion of barium to outline rectum and fluoroscopy to define change in rectal contour and expulsion of barium during the study.
Detailed Description:

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 to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women with no defecatory dysfunctionl

Criteria

Controls

Inclusion Criteria:

  • Women
  • No defecatory problems
  • On no medication which affect bowel habits

Exclusion Criteria:

  • Pregnancy

Patients

Inclusion Criteria:

  • Difficulty in defecation
  • Women

Exclusion criteria:

  • Pregnancy
  • Medication which can affect bowel movement
  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: NCT00219518

Locations
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
American College of Gastroenterology
Investigators
Principal Investigator: Ann Ouyang, MD Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Deputy director, ACG Institute for Clinical Research and Education
ClinicalTrials.gov Identifier: NCT00219518     History of Changes
Other Study ID Numbers: HY03-368
Study First Received: September 14, 2005
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Defecography
Pelvic floor dyssynergia
Anismus

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014