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Mechano-physiological Approach to Anorectal Function

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00219518
Enrollment
17
Registered
2005-09-22
Start date
2006-02-28
Completion date
2011-05-31
Last updated
2018-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

Defecography, Pelvic floor dyssynergia, Anismus

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.

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.

Interventions

PROCEDUREdefecography

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.

Sponsors

American College of Gastroenterology
CollaboratorOTHER
Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
change in shape of anorectum during changes in intraabdominal pressure and defecationstart of anorectal manometry procedure until procedure endmeasure change in dimension over time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026