Mechano-physiological Approach to Anorectal Function

May 23, 2018 updated by: Milton S. Hershey Medical Center

Mechano-physiological Approach to Normal Anorectal Function and the Classification of Defecatory Disorders

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with no defecatory dysfunctionl

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
start of anorectal manometry procedure until procedure end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

American College of Gastroenterology

Investigators

  • Principal Investigator: Ann Ouyang, MD, Penn State College of Medicine and Penn State Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HY03-368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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