safendoscopy: Endoscopy With Short Fasting

• Sponsor: Universidade de Passo Fundo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01492296
• Collaborator: Federal University of Rio Grande do Sul (Other)
• Enrollment: 115
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. safety [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• elective endoscopy

Exclusion Criteria:

• poor clinical condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Sao Vicente de Paulo	Passo Fundo	RS	Brazil

Sponsors and Collaborators

• Universidade de Passo Fundo
• Federal University of Rio Grande do Sul

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fernando Fornari, Clinical Professor, Universidade de Passo Fundo
• ClinicalTrials.gov Identifier: NCT01492296
• Other Study ID Numbers: safendoscopy
• First Posted: Dec 14, 2011
• Last Update Posted: Dec 14, 2011
• Last Verified: Dec 1, 2011

Study Results

No Results Posted as of Dec 14, 2011