Clinical trial NCT03819062: Sacral Neuromodulation as Treatment for Chronic Constipation
Official title: Sacral Neuromodulation as Treatment for Chronic Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Constipation
Keywords: Constipation
spinal cord injury
back pain
High-Resolution Colonic Manometry
Anorectal Manometry
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: proof of concept
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with severe chronic refractory constipation
* Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.

Exclusion Criteria:

* Pregnant patients
* Known malignancies in the area of treatment
* Active bleeding in area of treatment
* Active deep vein thrombosis
* When tatoos are present at area of treatment
* Patients that are light sensitive
* Patients who take NSAIDS or steroids.

Primary outcomes:
measure: Change in number of bowel movements/week
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in symptoms using the questionnaire PAC-SYM
timeFrame: 4 weeks
measure: Change in symptoms using the questionnaire PAC-SYM
timeFrame: 12 weeks
measure: Change in quality of life assessed by questionnaire PAC-QOL
timeFrame: 4 weeks
measure: Change in quality of life assessed by questionnaire PAC-QOL
timeFrame: 12 weeks
measure: Autonomic function assessment
timeFrame: 4 weeks
measure: Anal spincter pressure
timeFrame: 4 weeks
measure: Change in anal sphincter pressure due to attempting defecation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jihong Chen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
citation: Saito YA, Camilleri M. Editorial: patient assessment of constipation-symptoms (PAC-SYM) questionnaire has a minimal important difference. Aliment Pharmacol Ther. 2018 Jan;47(1):138-139. doi: 10.1111/apt.14389. No abstract available.