| 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 (in lay language) | One hour fast for water and six hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Preendoscopic preparation of patients | |
| 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 ? | |
| Study design | Randomized single blinded controlled trial | |
| 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 | |
| Target number / sample size | 96 | |
| Primary outcome(s) | 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 | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | Presence of complications | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/08/2005 | |
| Anticipated end date | 31/01/2006 | |
| Recruitment status | Completed | |
| State of ethics review approval | Ethical approval obtained from the Ethical Review Committee of Faculty of Medicine ,University of Kelaniya,Sri lanka | |
| Funding source(s) | Self funded | |
| Applicant's Email | apdsilva@yahoo.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr.Arjuna De Silva
Senior Lecturer, Consultant Physician Faculty of Medicine ,University of kelaniya PO box 06,Thalagolla Road ,Ragama 0112953409 0112958337 apdsilva@yahoo.com |
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| Primary Study Sponsor/ Organization | None
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| Contact Person for Public Queries | Dr.Arjuna De Silva Senior Lecturer, Consultant Physician Faculty of Medicine ,University of kelaniya PO box 06,Thalagolla Road ,Ragama 0112953409 0112958337 apdsilva@yahoo.com |
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| Secondary Study Sponsor(s), (if any) | None |
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