NCT01492296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

8 months

First QC Date

December 5, 2011

Last Update Submit

December 12, 2011

Conditions

Upper Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • quality

    10 min (endoscopy duration)

  • Endoscopy comfort

    8 hours

Study Arms (2)

conventional fasting

ACTIVE COMPARATOR

patients were evaluated after fasting for 8 hours

Procedure: conventional fasting

Short fasting

EXPERIMENTAL

patients who were evaluated with endoscopy after fasting for two hours

Procedure: endoscopy after short fasting

Interventions

endoscopy after short fastingPROCEDURE

patients were evaluated with endoscopy after fasting for two hours

Short fasting
conventional fastingPROCEDURE

patients were evaluated after fasting for 8 hours

conventional fasting

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective endoscopy

You may not qualify if:

  • poor clinical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • Koeppe AT, Lubini M, Bonadeo NM, Moraes I Jr, Fornari F. Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial. BMC Gastroenterol. 2013 Nov 9;13:158. doi: 10.1186/1471-230X-13-158.

    PMID: 24209639DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 14, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations

BR(1)