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Main
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Note: This record shows only the 20 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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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2008/005 |
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Date of registration:
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28/03/2008 |
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Primary sponsor: |
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Public title:
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One hour fast for water and six hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort
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Scientific title:
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One hour fast for water and six hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort |
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Date of first enrolment:
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1/8/2005 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={BAA73323-707A-4266-83A1-4AA332B5CFD4} |
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Study type:
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Interventional |
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Study design:
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Randomized single blinded controlled trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr.Arjuna De Silva
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Address:
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Faculty of Medicine ,University of kelaniya
PO box 06,Thalagolla Road ,Ragama
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Telephone:
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0112953409 |
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Email:
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apdsilva@yahoo.com |
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Affiliation:
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Senior Lecturer, Consultant Physician |
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Name:
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Dr.Arjuna De Silva
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Address:
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Faculty of Medicine ,University of kelaniya
PO box 06,Thalagolla Road ,Ragama
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Telephone:
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0112953409 |
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Email:
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apdsilva@yahoo.com |
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Affiliation:
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Senior Lecturer, Consultant Physician |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients referred to Professorial Medical unit of Colombo North Teaching Hospital, Ragama for routine upper GI endoscopy Age between 18 to 65 years
Informed written consent given
Exclusion criteria: Pregnancy
Presence of alarm symptoms
Previous gastric surgery
Clinically obvious motility disorders
Absence of inclusion criteria
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Preendoscopic preparation of patients
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Intervention(s)
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Patients are given a standard meal 6 hours before endoscopy.They are then randomized to either nil by mouth for 6 hours or allowed to drink water for upto one hour prior to endoscopy.They then undergo routine upper GI endoscopy
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Primary Outcome(s)
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Before endoscopy patients were requested to indicate discomfort from fasting on a visual analog scale.Fluid in the gastric fundus was aspirated if present for volume and pH measurements, and endoscopic vision graded
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Secondary Outcome(s)
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Presence of complications
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Source(s) of Monetary Support
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Self funded
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