Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reduction of Starvation Time Prior to Gastroscopy

NCT01670253

Habile Adult Patients Referred to the Elective Gastroscopy

TERMINATED NA

Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

NCT04411823

Gastroesophageal Reflux Sleeve Gastrectomy Bariatric Surgery Complication

RECRUITING NA

Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus

NCT02166957

Esophageal Disruption Esophageal Obstruction

COMPLETED

A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY

NCT02931123

Cirrhotic Patients Undergoing TIPS Placement

UNKNOWN PHASE1/PHASE2

Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

NCT04725695

Anesthetics, Local Esophagogastroduodenoscopy

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

EGDS Preparation; Fasting; Lumevis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

fasting from solids (6 hours before) and clear fluids (2 hours before the exam)

No interventions assigned to this group

Group B

Lumevis intake (50 ml), 30 minutes before the exam plus fasting as group A

Lumevis (IIa class)

Intervention Type DEVICE

intake of Lumevis 30 minutes before EGDS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lumevis (IIa class)

intake of Lumevis 30 minutes before EGDS

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes