EGDS Preparation; Fasting; Lumevis
Conditions
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.
Interventions
DEVICELumevis (IIa class)
intake of Lumevis 30 minutes before EGDS
Sponsors
Azienda USL Modena
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactMauro Manno
Outcome results
None listed