Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

• Conditions: EGDS Preparation; Fasting; Lumevis
• Interventions: Device: Lumevis (IIa class)

• Registration Number: NCT05401383
• Lead Sponsor: Azienda USL Modena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-02
• Study Start: 2022-12-01
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Lumevis (IIa class)	Lumevis intake (50 ml), 30 minutes before the exam plus fasting as group A

Primary Outcome Measures

Name	Time	Method
grade of mucosa visibility	6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mauro Manno; 🇮🇹 Carpi, MO, Italy