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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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1 March 2021 |
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Main ID: |
NCT04702646 |
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Date of registration:
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07/01/2021 |
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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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Patient and Colonoscopy Cleansing Quality Agreement
CALPER |
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Scientific title:
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Agreement Between Cleansing Quality Assessment During Colonoscopy and Patient Reported Cleansing Quality |
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Date of first enrolment:
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January 21, 2021 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04702646 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Antonio Z Gimeno Garcia, MD, hD |
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Address:
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Telephone:
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34922678039 |
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Email:
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antozeben@gmail.com |
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Affiliation:
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Name:
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Antonio Z Gimeno Garcia, MD, PhD |
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Address:
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Telephone:
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34-922678039 |
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Email:
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antozeben@gmail.com |
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Affiliation:
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Name:
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Antonio Z Gimeno Garcia, 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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Hospital Universitario de Canarias |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >18,
- to sign the informed consent
- patients with indication of outpatient colonoscopy
- patient ingesting preparation
Exclusion Criteria:
- Last colonoscopy with poor bowel preparation.
- Ileus, intestinal obstruction, megacolon.
- Poorly controlled hypertension (systolic hypertension> 180mmHg, dyastolic
hypertension> 100mmHg).
- Terminal renal failure (pre-dialysis or dialysis).
- Congestive heart failure (NYHA III-IV).
- Acute liver failure.
- Severe psychiatric illness.
- Dementia with difficulty in the intake of the preparation.
- Pregnancy or breastfeeding.
- Refusal to participate in the study.
- Allergies.
- Not looking at the characteristics of the last stool.
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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Cleansing Quality of the Colon
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Intervention(s)
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Drug: Bowel preparation before colonoscopy
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Procedure: Colonoscopy
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Primary Outcome(s)
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Quality of bowel cleansing
[Time Frame: [Time frame: 1 years][Designated as safety issue: No]]
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Secondary Outcome(s)
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Predictive factors associated to an adequate bowel cleansing
[Time Frame: [Time Frame: 1 years][Designated as safety issue: No]]
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Test the correlation between 3 sets of pictures and the cleansing quality following the Boston Bowel Preparation Scale
[Time Frame: [Time Frame: 6 months][Designated as safety issue: No]]
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Secondary ID(s)
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Colon cleansing agreement
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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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