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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02297399 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients
iDIMEPREP |
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Scientific 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. |
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Date of first enrolment:
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December 2, 2014 |
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Target sample size:
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158 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02297399 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Care Provider).
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Marco Antonio Alvarez González, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Parc de Salut Mar |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colonic Diseases
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Diabetes Mellitus
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Intervention(s)
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Drug: PEG-ascorbate 2L
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Drug: PEG 4L
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Primary Outcome(s)
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Tolerability of the bowel preparation (analogue visual scale)
[Time Frame: 6 hours after finishing bowel preparation]
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Secondary Outcome(s)
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Abdominal pain, nausea and bloating (analogue visual scale)
[Time Frame: 6 hours after finishing bowel preparation]
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Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)
[Time Frame: 6 hours after finishing bowel preparation]
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Adverse events
[Time Frame: 30 days after the colonoscopy]
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Adherence to the planned bowel cleansing method (questionnaire)
[Time Frame: 6 hours after finishing bowel preparation]
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Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
[Time Frame: 10 minutes after the colonoscopy]
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Ease of consumption and taste of the laxative (analogue visual scale)
[Time Frame: 6 hours after finishing bowel preparation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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