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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

December 5, 2011
December 12, 2011
March 2011
November 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01492296 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Endoscopy With Short Fasting
Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Upper Gastrointestinal Symptoms
  • 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
  • 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
Koeppe AT, Lubini M, Bonadeo NM, Moraes I Jr, Fornari F. Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial. BMC Gastroenterol. 2013 Nov 9;13(1):158. doi: 10.1186/1471-230X-13-158.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • elective endoscopy

Exclusion Criteria:

  • poor clinical condition
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01492296
safendoscopy
No
Fernando Fornari, Universidade de Passo Fundo
Universidade de Passo Fundo
Federal University of Rio Grande do Sul
Not Provided
Universidade de Passo Fundo
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP