Mechano-physiological Approach to Anorectal Function

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00219518
• Other study ID #: HY03-368
• Status: Terminated
• Start date: February 2006
• Est. completion date: May 2011

Study information

• Verified date: May 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

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.

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in shape of anorectum during changes in intraabdominal pressure and defecation	measure change in dimension over time	start of anorectal manometry procedure until procedure end