Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Parc de Salut Mar
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Efficacy of the bowel preparation
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for colonoscopy in diabetic patients.
Detailed Description
Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to follow one of two different sets of dietary recommendations. The experimental group will be asked to start a low-residue diet 4 days before the procedure, during which the therapy for diabetes will be adjusted. The control group will be asked to follow a low-residue diet for 3 days followed by a liquid diet during the day before the procedure, and no adjustments will be made to their usual treatment. Colon cleansing will be undertaken with polyethylene glycol (4 liters in the usual split administration scheme) in both groups. Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure
Investigators
Marco Antonio Alvarez Gonzalez
MD
Parc de Salut Mar
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
- •Diabetes mellitus (being treated with insulin or any oral agent).
Exclusion Criteria
- •Unwillingness to participate.
- •Hospital admission at the time of colonoscopy.
- •Inability to follow instructions
- •Active inflammatory bowel disease
- •Previous colectomy.
- •Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist
Outcomes
Primary Outcomes
Efficacy of the bowel preparation
Time Frame: 1 hour after the colonoscopy
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
Secondary Outcomes
- Acceptability of the preparation (interference with work, leisure activities or sleep(6 hours after finishing bowel preparation)
- Predictors of inadequate bowel preparation(Baseline)
- Polyp and adenoma detection(1 hour after the colonoscopy)
- Adverse events(30 days after the colonoscopy)
- Cecal intubation(1 hour after the colonoscopy)
- Abdominal pain, nausea, hunger and bloating(6 hours after finishing bowel preparation)
- Adherence to the planned bowel cleansing method (questionnaire)(6 hours after finishing bowel preparation)
- Symptomatic hypoglycemia(6 hours after finishing bowel preparation)