Endoscopy With Short Fasting (safendoscopy)
This study has been completed.
Sponsor:
Universidade de Passo Fundo
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
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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 More Information
No publications provided
| 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 Signs and Symptoms, Digestive Digestive System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013