Crohn Disease, Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).
Interventions
DRUGKleanLyte
Laxative for colonoscopy bowel preparation
DRUGBi-PegLyte
Laxative for colonoscopy bowel preparation
Sponsors
Canadian IBD Research Consortium (CIRC)
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy. 2. Age \> 18 years 3. Out-patients
Exclusion criteria
1. Prior subtotal or total colorectal resection 2. Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance. 3. Colonoscopy being repeated because of poor preparation in the preceding six months. 4. Allergies to the employed bowel preparations 5. Toxic megacolon, ileus, suspected or diagnosed bowel obstruction. 6. IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients. 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of bowel cleanliness | 1 year | The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by Boston Bowel Preparation Scale Score ≥2 in all segments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of laxative intake | 1 year | Will compare completion of laxative intake. |
| Endoscopic Outcomes | 1 year | Will compare dysplasia detection rate. |
| Patient experience data | 1 year | Will determine the proportion of patients in each group reporting: use of split dose and day before bowel preparation (even though they were prescribed split-dose) , incontinence episodes during bowel preparation and during travel to the colonoscopy appointment; total duration of sleep; number of nocturnal awakenings: patient willingness to repeat colonoscopy using the same preparation; pre-colonoscopy anxiety rating; difficulty with bowel preparation rating. The study specific patient questionnaire will be administered prior to the colonoscopy to avoid any contamination by the experience of the colonoscopy. |
| Crohn's disease or ulcerative colitis flares after colonoscopy | One month | A one month phone call to determine diagnosed flares within a month |
Countries
Canada
Contacts
Primary ContactJane Castelli
Outcome results
None listed