Colonic Diseases, Diabetes Mellitus
Conditions
Keywords
Colonoscopy, Diabetes Mellitus, Polyethylene glycols, Ascorbate, Personal satisfaction
Brief summary
This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.
Detailed description
Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to 2 different methods of colon cleansing before the procedure. Both will be based on the oral ingestion of a fluid solution (half of it on the evening before the procedure is planned and the rest on the morning of the same day), and the main difference between them will be the volume of fluid that will be ingested in each case. 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
DRUGPEG-ascorbate 2L
Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team. Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 2 sachets (labelled A and B) of the investigational product and take their contents diluted in 1 liter of water. Two other sachets, also labelled A and B, will be taken diluted in 1 liter of water 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.
DRUGPEG 4L
Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team. Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation 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 investigational product has been taken.
Sponsors
Germans Trias i Pujol Hospital
Parc de Salut Mar
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 |
|---|---|---|
| Tolerability of the bowel preparation (analogue visual scale) | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain, nausea and bloating (analogue visual scale) | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale. |
| Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire) | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in a questionnaire. |
| Ease of consumption and taste of the laxative (analogue visual scale) | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in an analogue visual scale. |
| Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS) | 10 minutes after the colonoscopy | Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist |
| Adverse events | 30 days after the colonoscopy | Description of any adverse event occurred during the study period |
| Adherence to the planned bowel cleansing method (questionnaire) | 6 hours after finishing bowel preparation | Each participant will rate his/her experience in a questionnaire. |
Countries
Spain
Outcome results
None listed