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
  Purpose

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 Intervention
Upper Gastrointestinal Symptoms
Procedure: endoscopy after short fasting
Procedure: conventional fasting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours

Resource links provided by NLM:


Further study details as provided by Universidade de Passo Fundo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 115
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective endoscopy

Exclusion Criteria:

  • poor clinical condition
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Universidade de Passo Fundo

Additional 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
Study First Received: December 5, 2011
Last Updated: December 12, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014