Home » Trials » SLCTR/2008/004


Is a six hour fast after a rice meal sufficient before upper gastrointestinal endoscopy? -

SLCTR Registration Number

SLCTR/2008/004


Date of Registration

28 Mar 2008

The date of last modification

Nov 21, 2017


Trial Status



Application Summary


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)


Trial Details


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


Assignment

Parallel


Purpose


Phase


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

2008-02-01


Date of first enrollment


Date of study completion


Recruitment status

Complete


Funding source

None



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


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


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results