This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
276
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
Hospital del Mar
Barcelona, Barcelona, Spain
Inadequate bowel preparation.
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
Time frame: 1 hour after the colonoscopy
Cecal intubation rate
Ratio of successful cecal intubations in each study arm
Time frame: 1 hour after the colonoscopy
Adenoma detection rate
Ratio of polyps and adenomas detected in each study arm
Time frame: 1 hour after the colonoscopy
Polyp detection rate
Ratio of polyps and adenomas detected in each study arm
Time frame: 1 hour after the colonoscopy
Abdominal pain
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Nausea
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Hunger
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Bloating
Each participant will rate his/her experience in an analogue visual scale
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 hours after finishing bowel preparation
Adverse events
Description of all spontaneously reported adverse events.
Time frame: 30 days after the colonoscopy
Adherence to the planned bowel cleansing method (questionnaire)
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation