Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

Study Overview
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Brief Summary
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One of the major problems for the endoscopist during esophagogastroduodenoscopy (EGDS) is the presence of foam, bubbles, mucus and saliva, whether small or large, which can compromise correct endoscopic visibility. Endoscopy of the upper gastrointestinal tract, like that of the lower gastrointestinal tract, requires optimal visualization of the mucosa. It is clear that endoscopic vision is often hindered by the presence of bubbles and foam: multiple aspirations alternating with intraprocedural washes are therefore necessary, which lengthen the time necessary for the endoscopic examination. Nowadays there's no universal raccomandation about a specific preparation before EGDS. The aim of our study is to compare fasting versus the use of simethicone premedication in combination with N-acetyl- cysteine and acetic acid (LumevisTM). The study is observational, randomized 1:1, and double blind. Primary outcomes are: grade of mucosa visualization defined by visual analogue scale (0-10) for each analyzed segment (esophagus, stomach and duodenum). Secondary aims: general patient satisfaction defined by visual analogue scale, eventual adverse events, duration of the exam.

Official Title
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Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis

Conditions
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EGDS Preparation; Fasting; Lumevis

Intervention / Treatment
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* Device: Lumevis (IIa class)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients that underwent EGDS Exclusion Criteria: previous upper GI surgery previous endoscopic bariatric procedures known upper GI stenosis (benign and malign) previous diagnosis of achalasia or motility disorders diabetes allergy to one of lumevis components cystinuria fasting not correctly respected pregnant or brest-feeding women urgent-emercengy setting inpatients patients who don't give their consent to partecipate to the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>fasting from solids (6 hours before) and clear fluids (2 hours before the exam) | |
| Group B<br>Lumevis intake (50 ml), 30 minutes before the exam plus fasting as group A | Device: Lumevis (IIa class)<br>* intake of Lumevis 30 minutes before EGDS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade of mucosa visibility | evalueted by VAS after the exam (it will be recorded a video) by a physician that not performed the exam and that are blinded about the randomization | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general patient satisfaction | evalueted by VAS at the end of the exam, before the discharge to home | 6 months | 
| eventual adverse events | evalueted by ASGE lexicon, at the end of the exam, before the discharge to home | 6 months | 
| duration of the exam | minutes between intubation and extubation of the endoscope from the mouth | 6 months |