Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechano-physiological Approach to Anorectal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00219518
Recruitment Status : Terminated (inadequate no of constip patients)
First Posted : September 22, 2005
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Constipation Procedure: defecography

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechano-physiological Approach to Normal Anorectal Function and the Classification of Defecatory Disorders
Study Start Date : February 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. change in shape of anorectum during changes in intraabdominal pressure and defecation [ Time Frame: start of anorectal manometry procedure until procedure end ]
    measure change in dimension over time


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219518


Locations
Layout table for location information
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
American College of Gastroenterology
Investigators
Layout table for investigator information
Principal Investigator: Ann Ouyang, MD Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00219518     History of Changes
Other Study ID Numbers: HY03-368
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Keywords provided by Milton S. Hershey Medical Center:
Defecography
Pelvic floor dyssynergia
Anismus

Additional relevant MeSH terms:
Layout table for MeSH terms
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms