Endoscopy With Short Fasting (safendoscopy)

This study has been completed.

Sponsor:

Collaborator:

Federal University of Rio Grande do Sul

Information provided by (Responsible Party):

Fernando Fornari, Universidade de Passo Fundo

ClinicalTrials.gov Identifier:

NCT01492296

First received: December 5, 2011

Last updated: December 12, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 5, 2011
Last Updated Date	December 12, 2011
Start Date ^ICMJE	March 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 12, 2011)	safety [ Time Frame: 10 min (endoscopy duration) ] [ Designated as safety issue: Yes ] safety of endoscopy after fasting for two hours will be assessed by means of a questionnaire replied by the endoscopists, questioning occurrence of aspiration and regurgitation of gastric contents into the esophagus.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01492296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 12, 2011)	quality [ Time Frame: 10 min (endoscopy duration) ] [ Designated as safety issue: No ] Quality of endoscopy will be assessed by means of a questionnaire replied by the endoscopists, including (1) presence of liquid in the gastric lumen (2) quality of mucosa visualization (3)period needed for gastric aspiration Endoscopy comfort [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ] Endoscopy comfort will be evaluated by the patients by means of a questionnaire replied after the procedures. It will include questions about thirst, hunger, anxiety, weakness and nausea.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Endoscopy With Short Fasting
Official Title ^ICMJE	Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours
Brief Summary	Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. In recent studies, surgical cholecystectomy has been described to be safe after two hours of fasting on liquids. The aim of this study is to assess safety, quality and comfort of upper GI endoscopy after two hours of fasting.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Condition ^ICMJE	Upper Gastrointestinal Symptoms
Intervention ^ICMJE	Procedure: endoscopy after short fasting patients were evaluated with endoscopy after fasting for two hours Procedure: conventional fasting patients were evaluated after fasting for 8 hours
Study Arm (s)	Active Comparator: conventional fasting patients were evaluated after fasting for 8 hours Intervention: Procedure: conventional fasting Experimental: Short fasting patients who were evaluated with endoscopy after fasting for two hours Intervention: Procedure: endoscopy after short fasting
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: elective endoscopy Exclusion Criteria: poor clinical condition
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01492296
Other Study ID Numbers ^ICMJE	safendoscopy
Has Data Monitoring Committee	No
Responsible Party	Fernando Fornari, Universidade de Passo Fundo
Study Sponsor ^ICMJE	Universidade de Passo Fundo
Collaborators ^ICMJE	Federal University of Rio Grande do Sul
Investigators ^ICMJE	Not Provided
Information Provided By	Universidade de Passo Fundo
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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