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The objective of this study is to study if low level laser therapy will do more good than harm for patients with severe chronic refractory constipation. It is a proof of concept study without a placebo arm.
Patients will be offered the therapy if High-Resolution Colonic Manometry has shown that coordination between colon motility and recto-anal activity is abnormal and that autonomic nervous system assessment suggests a dysfunction of communication between the spinal cord autonomic nerves and the colon-rectum-anus. The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptom and quality of life questionnaires and physiological assessments of colon and pelvic floor function, at 4 weeks and 12 weeks.
Age
6 - 70 years
Sex
ALL
Healthy Volunteers
No
McMaster University
Hamilton, Ontario, Canada
Start Date
September 8, 2019
Primary Completion Date
February 1, 2025
Completion Date
February 1, 2027
Last Updated
April 5, 2022
20
ESTIMATED participants
Low Level Laser Therapy
DEVICE
Lead Sponsor
McMaster University
NCT06847919
NCT06354855
NCT06850415
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