Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

Study Overview
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Brief Summary
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This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.

Detailed Description
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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

Official Title
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Improvement of Tolerability for Bowel Preparation for Colonoscopy in Diabetic Patients. A Randomized Controlled Trial of Two Bowel Preparation Protocols Including 4 Liters PEG vs. 2 Liters PEG Plus Ascorbic Acid. iDIMEPREP Study.

Conditions
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Diabetes Mellitus, Colonic Diseases

Intervention / Treatment
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* Drug: PEG-ascorbate 2L
* Drug: PEG 4L


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-ascorbate 2L<br>Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution. | Drug: PEG-ascorbate 2L<br>* 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.<br>* Other names: Moviprep®;|
| Active Comparator: PEG 4L<br>Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution. | Drug: PEG 4L<br>* 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.<br>* Other names: Bohm®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of the bowel preparation (analogue visual scale) | Each participant will rate his/her experience in an analogue visual scale. | 6 hours after finishing bowel preparation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of consumption and taste of the laxative (analogue visual scale) | Each participant will rate his/her experience in an analogue visual scale. | 6 hours after finishing bowel preparation | 
| Abdominal pain, nausea and bloating (analogue visual scale) | Each participant will rate his/her experience in an analogue visual scale. | 6 hours after finishing bowel preparation | 
| Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire) | Each participant will rate his/her experience in a questionnaire. | 6 hours after finishing bowel preparation | 
| Adherence to the planned bowel cleansing method (questionnaire) | Each participant will rate his/her experience in a questionnaire. | 6 hours after finishing bowel preparation | 
| Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS) | Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist | 10 minutes after the colonoscopy | 
| Adverse events | Description of any adverse event occurred during the study period | 30 days after the colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Diabetes Mellitus, Polyethylene glycols, Ascorbate, Personal satisfaction