Status:
UNKNOWN
Efficacy and Safety of Split-dose Citrafleet Administered From 2 to 6 Hours Before Morning Colonoscopies
Lead Sponsor:
Infante, Javier Molina, M.D.
Conditions:
Bowel Cleansing
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy. Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged procedure du...
Detailed Description
Justification of the study: Several split-dose bowel cleansing regimens have raised over the last decade aiming to substitute standard preparation the day before. These split-dose regimens (based on ...
Eligibility Criteria
Inclusion
- all patients undergoing routine elective colonoscopy
Exclusion
- pregnant or lactating women
- age less than 18 years
- significant gastroparesis or gastric outlet obstruction or ileus
- known or suspected bowel obstruction or perforation
- phenylketonuria or glucose-6-phosphate dehydrogenase deficiency
- severe chronic renal failure (creatinine clearance \< 30 mL/minute)
- severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
- dehydration
- severe acute inflammatory disease
- compromised swallowing reflex or mental status
- uncontrolled hypertension (systolic blood pressure \> 170 mm Hg ad/or diastolic blood pressure \> 100 mm Hg)
- toxic colitis
- megacolon
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01481714
Start Date
November 1 2011
End Date
June 1 2012
Last Update
November 29 2011
Active Locations (1)
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1
Hospital San Pedro de Alcantara
Cáceres, Caceres, Spain, 10003