Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

Not Applicable

• Conditions: Patients Undergoing Diagnostic EGD
• Interventions: Procedure: traditional air insufflation; Procedure: Gastric water exchange

• Registration Number: NCT04502485
• Lead Sponsor: Yu-Hsi hsieh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional air insufflation	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.
Gastric water exchange	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.

Primary Outcome Measures

Name	Time	Method
Discomfort during the procedure	5 minutes after the procedure	A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,

Secondary Outcome Measures

Name	Time	Method
mucosa cleanliness score	1 minutes after the procedure	1, no need for irrigation; 4, need more than 50 ml of water irrigation
patient satisfaction score	5 minutes after the procedure	A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient
technique adequacy score	1 minutes after the procedure	1, excellent; 6, very poor

Trial Locations

Locations (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; 🇨🇳 Chiayi, Taiwan