Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy
1 other identifier
interventional
250
1 country
1
Brief Summary
The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 6, 2020
August 1, 2020
2.2 years
August 4, 2020
August 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Discomfort during the procedure
A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,
5 minutes after the procedure
Secondary Outcomes (3)
patient satisfaction score
5 minutes after the procedure
mucosa cleanliness score
1 minutes after the procedure
technique adequacy score
1 minutes after the procedure
Study Arms (2)
Gastric water exchange
EXPERIMENTALAir will be minimally insufflated to partially open the lumen and any residual fluid will be suctioned when the scope passes through the esophagus. Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further. Air will be opened when the scope enter the prepylorus area where there is usually an air pocket. The scope will enter the duodenal bulb and 2nd portion of duodenum where withdrawal inspection will start.
Traditional air insufflation
ACTIVE COMPARATORAir will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase.
Interventions
Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further.
Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase.
Eligibility Criteria
You may qualify if:
- Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment
You may not qualify if:
- a therapeutic EGD
- sedation with other agents
- American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
- age less than 20 years or more than 65 years
- pregnancy
- refusal to provide written informed consent. All participants signed written informed consents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yu-Hsi hsiehlead
Study Sites (1)
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, Taiwan, 622, Taiwan
Related Publications (2)
Abraham N, Barkun A, Larocque M, Fallone C, Mayrand S, Baffis V, Cohen A, Daly D, Daoud H, Joseph L. Predicting which patients can undergo upper endoscopy comfortably without conscious sedation. Gastrointest Endosc. 2002 Aug;56(2):180-9. doi: 10.1016/s0016-5107(02)70175-2.
PMID: 12145594BACKGROUNDMeining A, Semmler V, Kassem AM, Sander R, Frankenberger U, Burzin M, Reichenberger J, Bajbouj M, Prinz C, Schmid RM. The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam. Endoscopy. 2007 Apr;39(4):345-9. doi: 10.1055/s-2006-945195. Epub 2007 Feb 7.
PMID: 17285514BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 6, 2020
Study Start
May 1, 2019
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 6, 2020
Record last verified: 2020-08