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Comparison of the Efficacy between Biofeedback plus Laxatives Therapy Group and Laxatives Therapy Group in Dyssynergic Defecation Associated with Spinal Cord Disease: A Prospective Randomized Controlled Trial

Not Applicable
Conditions
Diseases of the digestive system
Registration Number
KCT0000337
Lead Sponsor
Asan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

?Patients between 20 years and 65 years old at age and with previous history of spinal cord injury or disease
?Patients whose spinal cord disease were comfirmed by the physicians who were major in the rehabilitation medicine, neurology,or neurosurgery.
?Patients with minimal or no neurologic sequalae and able to walk independently or by depending on the cane
?Constipation with the definite chronological relationship to the spinal cord diseases
?At least two studies suggests dyssyngergic defecation by the physiologic studies such as anorectal manometry, balloon expulsion test, colonic transit time study, and defecography
?Constipation which is not responded to dietery intervention and one kind of laxative

Exclusion Criteria

?Patients who were unable to walk independently because of the neurologic deficit of spinal cord diseases
?Patients who had constipation before the development of spinal cord injury
?Patients with mild constipation which was responded to dietery intervention and one kind of osmotic laxative.
?Patients with organic lesions except spinal cord diseases which may develop constipation
?Patients who underwent gastric or bowel resection surgery
?Patients with untreated intraabdominal or intrapelvic malignancies
?Patients with uncontrolled hypothyroidism
?Patients with sequalae caused by neurologic disorders except spinal cord disease, such as stroke, parkinsonism, brain tumor, and so on
?Patients with uncompensated cardipulmonary disease
?Patients who did not agree with the participation to this study

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Global defecatory satisfaction score
Secondary Outcome Measures
NameTimeMethod
Anorectal manometry results
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