Low-fiber Diet for Colorectal Cancer Screening Colonoscopy
- Conditions
- Colonic Diseases
- Interventions
- Dietary Supplement: Usual careDietary Supplement: Low-residue diet
- Registration Number
- NCT02401802
- Lead Sponsor
- Parc de Salut Mar
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet. Laxative 4 liters polyethylene glycol 4000 in split fashion. Low-residue diet Low-residue diet The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cecal intubation rate 1 hour after the colonoscopy Ratio of successful cecal intubations in each study arm
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
Hunger 6 hours after finishing bowel preparation Each participant will rate his/her experience in an analogue visual scale
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.
Trial Locations
- Locations (1)
Hospital del Mar
🇪🇸Barcelona, Spain