Sacral Neuromodulation as Treatment for Chronic Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Level Laser Therapy.
- Who it may be relevant to
- Registry conditions: Chronic Constipation. Basic parameters: 6 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Low Level Laser Therapy
A 3 week treatment period with 8 treatment sessions in total.
Primary outcome measures
- Change in number of bowel movements/week [Time frame: 12 weeks]
Secondary outcome measures (7)
- Change in symptoms using the questionnaire PAC-SYM [Time frame: 4 weeks]
- Change in symptoms using the questionnaire PAC-SYM [Time frame: 12 weeks]
- Change in quality of life assessed by questionnaire PAC-QOL [Time frame: 4 weeks]
- Change in quality of life assessed by questionnaire PAC-QOL [Time frame: 12 weeks]
- Autonomic function assessment [Time frame: 4 weeks]
- Anal spincter pressure [Time frame: 4 weeks]
- Change in anal sphincter pressure due to attempting defecation [Time frame: 4 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McMaster University — Hamilton
Publications
- 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. PMID 16036506
- 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. PMID 29226416
Identifiers
NCT: NCT03819062 · McMasterChenC