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Endoscopy With Short Fasting (safendoscopy)

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ClinicalTrials.gov Identifier: NCT01492296
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : December 14, 2011
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Fernando Fornari, Universidade de Passo Fundo

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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Symptoms Procedure: endoscopy after short fasting Procedure: conventional fasting Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: conventional fasting
patients were evaluated after fasting for 8 hours
Procedure: conventional fasting
patients were evaluated after fasting for 8 hours
Experimental: Short fasting
patients who were evaluated with endoscopy after fasting for two hours
Procedure: endoscopy after short fasting
patients were evaluated with endoscopy after fasting for two hours



Primary Outcome Measures :
  1. safety [ Time Frame: 10 min (endoscopy duration) ]
    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.


Secondary Outcome Measures :
  1. quality [ Time Frame: 10 min (endoscopy duration) ]
    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

  2. Endoscopy comfort [ Time Frame: 8 hours ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective endoscopy

Exclusion Criteria:

  • poor clinical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492296


Locations
Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, RS, Brazil
Sponsors and Collaborators
Universidade de Passo Fundo
Federal University of Rio Grande do Sul

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Fornari, Clinical Professor, Universidade de Passo Fundo
ClinicalTrials.gov Identifier: NCT01492296     History of Changes
Other Study ID Numbers: safendoscopy
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases