An observational study in EGDS Preparation; Fasting; Lumevis, sponsored by Azienda USL Modena. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Azienda USL Modena · Observational
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.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 74 observational studies indexed under Fasting.
Browse Fasting studies →Azienda USL Modena is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients who had to perform EGDS
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Exclusion Criteria:
fasting from solids (6 hours before) and clear fluids (2 hours before the exam)
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
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
Time frame: 6 months
general patient satisfaction
evalueted by VAS at the end of the exam, before the discharge to home
Time frame: 6 months
eventual adverse events
evalueted by ASGE lexicon, at the end of the exam, before the discharge to home
Time frame: 6 months
duration of the exam
minutes between intubation and extubation of the endoscope from the mouth
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Mar 2023, 3 months after the start.
Of 46 non-industry observational studies under Fasting, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's planned 3 months is below that.
Counting every sponsor, half of 48 studies reached it within 17 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Azienda USL Modena