Colorectal Cancer
Conditions
Keywords
Colonoscopy, Colorectal screening, Colon preparation
Brief summary
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure. The principal research questions are: 1. Does the use of a low residue diet increase patient concordance to the bowel preparation instructions? 2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa? 3. Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up? 4. Does body weight affect perceived tolerability of either group?
Interventions
OTHERlow residue diet
Fleet (usual preparation) plus diet sheet for low residue diet
Sponsors
Action Cancer
Western Health and Social Care Trust
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients attending for Colonoscopy. * Patients referred for colonoscopy via General Practitioner.
Exclusion criteria
* Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required) * Previous episodes of total or partial small bowel obstruction * Previous colonic surgery * Known swallowing disorder * Pregnancy * Extremes of age (Less than 16 or greater than 80) * Small Intestine disorders * Renal Insufficiency (Serum Creatinine\> 110) * Congestive Heart failure * Presence of ascites * Severe Colitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clarity of the mucosa evaluated by the Ottawa Scale. | At endoscopy screening |
Secondary
| Measure | Time frame |
|---|---|
| Concordance with the bowel preparation. | Prior to the endoscopy |
Countries
United Kingdom
Contacts
Primary ContactDaphne Garrett
Backup ContactSiobhan McCann, PhD
Outcome results
None listed