Colonic Diseases, Diabetes Mellitus
Conditions
Keywords
Colonoscopy, Diabetes Mellitus, Diet, Polyethylene glycols, Efficacy, Personal satisfaction
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
Interventions
DIETARY_SUPPLEMENTLow-residue diet
Subjects will be instructed by members of the research team to follow a low-residue diet for 4 days. Bowel cleansing will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the bowel cleansing is complete. Their usual treatment for diabetes (whether insulin or an oral agent) will be adjusted.
DIETARY_SUPPLEMENTUsual care
Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by a liquid-only diet for an additional day. Bowel cleansing will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the bowel cleansing is complete. No modifications in their usual treatment will be made.
Sponsors
Parc de Salut Mar
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the bowel preparation | 1 hour after the colonoscopy | Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp and adenoma detection | 1 hour after the colonoscopy | Ratio of polyps and adenomas detected in each study arm |
| Symptomatic hypoglycemia | 6 hours after finishing bowel preparation | Each participant will report his/her experience in a questionnaire |
| Abdominal pain, nausea, hunger and bloating | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale |
| Cecal intubation | 1 hour after the colonoscopy | Ratio of successful cecal intubations in each study arm |
| 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. |
| Predictors of inadequate bowel preparation | Baseline | Independent predictors will be identified by multivariate analysis |
| Adverse events | 30 days after the colonoscopy | Description of all spontaneously reported adverse events. |
Countries
Spain
Outcome results
None listed