Home » Trials » SLCTR/2008/004
Is a six hour fast after a rice meal sufficient before upper gastrointestinal endoscopy?
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SLCTR Registration Number
SLCTR/2008/004
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Is a six hour fast after a rice meal sufficient before upper gastrointestinal endoscopy?
Public Title of Trial
Is a six hour fast after a rice meal sufficient before upper gastrointestinal endoscopy?
Disease or Health Condition(s) Studied
Preendoscopic preparation of patients undergoing toutine endoscopy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P92/12/2007 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
To determine if fasting six hours after a rice meal is sufficient before upper gastrointestinal endoscopy ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
100 patients will be given a standard bread based meal and fast for six hours.100 patients are given an isocaloric rice based meal and fast for 6 hours while another 100 patients given the same diet will fast for 10 hours They will then undergo routine endoscopy
Inclusion criteria
Patients who have been referred to the Professorial unit of the Colombo North Teaching Hospital for routine endoscopy Age between 18 and 65 years
Exclusion criteria
Patients not fulfilling inclusion criteria Patients with alarm symptoms(bleeding,weight loss,dysphagia) Clinically obvious motility disorders Pregnancy
Primary outcome(s)
|
1.
Clarity of endoscopic vision and presence of fluid in the fundus of the stomach assessed by an endoscopist blind to the preendoscopic preparation of the patient |
[ During endoscopy ] |
Secondary outcome(s)
|
1.
Any complications post endoscopy |
[ After endoscopy ] |
Target number/sample size
300
Countries of recruitment
Sri Lanka
Anticipated start date
2008-02-01
Anticipated end date
2008-08-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2007-12-12
Approval number
P92/12/2007
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.Arjuna De Silva
Senior Lecturer and Consultant Physician
Faculty of Medicine,University of Kelaniya
PO box 06,Thalagolla Road, Ragama
0112953409
0112958337
apdsilva@yahoo.com
Contact Person for Public Queries
Dr.Arjuna De Silva
Senior Lecturer and Consultant Physician
Faculty of Medicine,University of Kelaniya
PO box 06,Thalagolla Road, Ragama
0112953409
0112958337
apdsilva@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
