Mechano-physiological Approach to Anorectal Function

Terminated

• Conditions: Constipation

• Registration Number: NCT00219518
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Start: 2006-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in shape of anorectum during changes in intraabdominal pressure and defecation	start of anorectal manometry procedure until procedure end	measure change in dimension over time

Trial Locations

Locations (1)

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States