Colonic Diseases
Conditions
Keywords
Colonoscopy, Diet, Polyethylene glycols, Efficacy, Personal satisfaction, Colorectal cancer screening
Brief summary
This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.
Detailed description
There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability. All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.
Interventions
Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days
Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet
Sponsors
Study design
Eligibility
Inclusion criteria
* Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.
Exclusion criteria
* Unwillingness to participate. * Inability to follow instructions * Active inflammatory bowel disease * Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inadequate bowel preparation. | 1 hour after the colonoscopy | The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 1 hour after the colonoscopy | Ratio of polyps and adenomas detected in each study arm |
| Polyp detection rate | 1 hour after the colonoscopy | Ratio of polyps and adenomas detected in each study arm |
| Abdominal pain | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale |
| Nausea | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale |
| Cecal intubation rate | 1 hour after the colonoscopy | Ratio of successful cecal intubations in each study arm |
| Bloating | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale |
| Adverse events | 30 days after the colonoscopy | Description of all spontaneously reported adverse events. |
| Adherence to the planned bowel cleansing method (questionnaire) | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in a questionnaire. |
| Acceptability of the preparation (interference with work, leisure activities or sleep | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in a questionnaire. |
| Hunger | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale |
Countries
Spain