Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

NCT05401383 | Unknown

• 1 other identifier: AziendaUSLModena
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

EGDS Preparation; Fasting; Lumevis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• general patient satisfaction

  6 months

• eventual adverse events

  6 months

• duration of the exam

  6 months

Study Arms (2)

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)

Interventions

Lumevis (IIa class) DEVICE

intake of Lumevis 30 minutes before EGDS

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients who had to perform EGDS

You may qualify if:

• adult patients that underwent EGDS

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Modena: lead

Study Sites (1)

Mauro Manno

Carpi, MO, 41012, Italy

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Mauro Manno

CONTACT

0039 059659250; m.manno@ausl.mo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology and Digestive Endoscopy Unit

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: December 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 6, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)