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Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

Sponsor
Azienda USL Modena (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401383
Collaborator
(none)
100
Enrollment
6.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Lumevis (IIa class)

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. general patient satisfaction [6 months]

    evalueted by VAS at the end of the exam, before the discharge to home

  2. eventual adverse events [6 months]

    evalueted by ASGE lexicon, at the end of the exam, before the discharge to home

  3. duration of the exam [6 months]

    minutes between intubation and extubation of the endoscope from the mouth

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Azienda USL Modena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Mauro Manno, Director of Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena
ClinicalTrials.gov Identifier:
NCT05401383
Other Study ID Numbers:
  • AziendaUSLModena
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 2, 2022