NCT05401383

Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Azienda USL Modena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Lumevis (IIa class)	intake of Lumevis 30 minutes before EGDS

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-06-02
• Last updated: 2023-02-06

Locations

1 site across 1 country: Italy