Mechano-physiological Approach to Anorectal Function

NCT ID: NCT00219518

Last Updated: 2018-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Constipation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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


* Difficulty in defecation
* Women

Exclusion Criteria

* Pregnancy

Patients


* Pregnancy
* Medication which can affect bowel movement
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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American College of Gastroenterology

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Ouyang, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine and Penn State Milton S. Hershey Medical Center

Locations

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Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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HY03-368

Identifier Type: -

Identifier Source: org_study_id

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