Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis

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.

Study Overview

• Status: Recruiting
• Conditions: EGDS Preparation; Fasting; Lumevis
• Intervention / Treatment: Device: Lumevis (IIa class)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mauro Manno; Phone Number: 0039 059659250; Email: m.manno@ausl.mo.it

Study Locations

• Italy
  • MO
    • Carpi, MO, Italy, 41012
      • Recruiting
      • Mauro Manno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult patients who had to perform EGDS

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; fasting from solids (6 hours before) and clear fluids (2 hours before the exam)
Group B; Lumevis intake (50 ml), 30 minutes before the exam plus fasting as group A	Device: Lumevis (IIa class); intake of Lumevis 30 minutes before EGDS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda USL Modena

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2022
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AziendaUSLModena

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No