Home » Trials » SLCTR/2008/005
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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SLCTR Registration Number
SLCTR/2008/005
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
One hour fast for water and six hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort
Public Title of Trial
One hour fast for water and six hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort
Disease or Health Condition(s) Studied
Preendoscopic preparation of patients
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
To determine whether a 6 hour fast for solids and one hour fast for water prior to UGIE was effective and resulted in less patient discomfort ?
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
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
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
Primary outcome(s)
|
1.
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)
|
1.
Presence of complications |
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Target number/sample size
96
Countries of recruitment
Anticipated start date
2005-08-01
Anticipated end date
2006-01-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2005-12-12
Approval number
Not Available
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
0112958337
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
0112958337
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
