Hospital del Mar
Barcelona, 08003, Spain
NCT Number: NCT02401802
This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08003, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: 1 hour after the colonoscopy
Ratio of successful cecal intubations in each study arm
Time frame: 1 hour after the colonoscopy
Ratio of polyps and adenomas detected in each study arm
Time frame: 1 hour after the colonoscopy
Ratio of polyps and adenomas detected in each study arm
Time frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale
Time frame: 30 days after the colonoscopy
Description of all spontaneously reported adverse events.
Time frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in a questionnaire.
Parc de Salut Mar
Other
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
Acronym: DIETCOL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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