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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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19 September 2016 |
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Main ID: |
NCT02887014 |
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Date of registration:
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15/08/2016 |
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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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Specific Verbal vs. Usual Instructions for Inpatients Undergoing Colonoscopy
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Scientific title:
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Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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300 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02887014 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Konstantinos Triantafyllou, Ass. Prof. |
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Address:
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Telephone:
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00302105832087 |
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Email:
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ktriant@med.uoa.gr |
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Affiliation:
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Name:
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Konstantinos Triantafyllou, Ass. Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Attikon Hospital |
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Name:
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KONSTANTINOS TRIANTAFYLLOU, Ass. Prof. |
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Address:
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Telephone:
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00302105832090 |
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Email:
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ktriant@med.uoa.gr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- assignment of informed consent
Exclusion Criteria:
- inability to provide informed consent
- history of colectomy
- indication for rectosigmoidoscopy
- lack of knowledge of the Greek language.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adequate Colonoscopy Preparation for Inpatients
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Intervention(s)
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Procedure: SPECIFIC VERBAL INSTRUCTIONS
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Primary Outcome(s)
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Increase in the number of examinations with adequate bowel preparation
[Time Frame: At colonoscopy completion]
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Secondary Outcome(s)
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Identification of potential additional risk factors for inadequate preparation
[Time Frame: After colonoscopy completion]
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Total examination time, cecal intubation time and time needed to washout during the colonoscopy
[Time Frame: At colonoscopy completion]
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Patient satisfaction from the bowel preparation using the visual analogue scale.
[Time Frame: After colonoscopy completion]
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Cecal intubation rate
[Time Frame: At cecum intubation]
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Polyp and adenoma detection rate (overall and per segment)
[Time Frame: Up to 4 weeks after patient's enrollment]
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Percentage of patients who received the whole amount of liquid preparation
[Time Frame: Before colonoscopy start]
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Segmental BBPS score changes
[Time Frame: At colonoscopy completion]
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Overall BBPS score change
[Time Frame: At colonoscopy completion]
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Side effects related either to the preparation or the examination
[Time Frame: Before colonoscopy start]
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Secondary ID(s)
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INPATIENTS_VERBAL-001
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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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