Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Contr… (NCT02357303) | Clinical Trial Compass
CompletedPhase 4
Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial
Portugal300 participantsStarted 2015-04
Plain-language summary
The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions.
Before an upper endoscopy it is required a 6 hour fasting period\[1\]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus.
To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure.
The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* consecutive series of patients scheduled for upper gastrointestinal endoscopy
* signed informed consent
Exclusion Criteria:
* sedation
* previous total gastrectomy
* known neoplasia or stenosis
* therapeutic or urgent procedures
* allergies to simethicone or N-acetylcysteine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.