Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Undergoing Diagnostic EGD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gastric water exchange

Air 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.

Group Type EXPERIMENTAL

Gastric water exchange

Intervention Type PROCEDURE

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.

Traditional air insufflation

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.

Group Type ACTIVE_COMPARATOR

traditional air insufflation

Intervention Type PROCEDURE

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.

Interventions

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Gastric water exchange

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.

Intervention Type PROCEDURE

traditional air insufflation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No