Endoscopy With Short Fasting

Upper Gastrointestinal Symptoms Clinical Trial

— safendoscopy  

Official title:

Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492296
• Other study ID #: safendoscopy
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: December 12, 2011
• Start date: March 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• elective endoscopy

Exclusion Criteria:

• poor clinical condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Upper Gastrointestinal Symptoms

Intervention

Procedure:
• endoscopy after short fasting
patients were evaluated with endoscopy after fasting for two hours
• conventional fasting
patients were evaluated after fasting for 8 hours

Locations

Country	Name	City	State
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo	RS

Sponsors (2)

Lead Sponsor	Collaborator
Universidade de Passo Fundo	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety	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.	10 min (endoscopy duration)	Yes
Secondary	quality	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	10 min (endoscopy duration)	No
Secondary	Endoscopy comfort	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.	8 hours	Yes