Sacral Neuromodulation as Treatment for Chronic Constipation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedStudy Start
First participant enrolled
September 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedApril 5, 2022
April 1, 2022
5.4 years
January 16, 2019
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in number of bowel movements/week
(significance level P\<0.05 comparing before and after).
12 weeks
Secondary Outcomes (7)
Change in symptoms using the questionnaire PAC-SYM
4 weeks
Change in symptoms using the questionnaire PAC-SYM
12 weeks
Change in quality of life assessed by questionnaire PAC-QOL
4 weeks
Change in quality of life assessed by questionnaire PAC-QOL
12 weeks
Autonomic function assessment
4 weeks
- +2 more secondary outcomes
Study Arms (1)
Refractory Constipation with LLLT
EXPERIMENTALLow level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation
Interventions
A 3 week treatment period with 8 treatment sessions in total.
Eligibility Criteria
You may qualify if:
- Patients with severe chronic refractory constipation
- Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8N3Z5, Canada
Related Publications (2)
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: 16036506BACKGROUNDSaito 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: 29226416BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihong Chen, MD PhD
McMaster University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 16, 2019
First Posted
January 28, 2019
Study Start
September 8, 2019
Primary Completion
February 1, 2025
Study Completion (Estimated)
February 1, 2027
Last Updated
April 5, 2022
Record last verified: 2022-04