The timing of administration of simethicone influences mucosal visibility during upper endoscopy
ID
Bron
Verkorte titel
Aandoening
All patients with an indication for an upper endoscopy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total mucosal visibility
Achtergrond van het onderzoek
We will evaluate the effect on the mucosal visibility when simethicone is administered shortly before upper endoscopy, at patients’ arrival at the endoscopy department, or when simethicone is administered as split-dose on both time points. This is a multicenter, prospective, randomized, endoscopist-blinded study.
Doel van het onderzoek
The timing of administration of simethicone influences mucosal visibility during upper endoscopy
Onderzoeksopzet
During upper endoscopy, 9 standardized pictures of the esophagus, stomach and duodenum will be taken. These pictures will be assessed on mucosal visibility by 3 independent, blinded endoscopists by a predefined scoring system.
Also, during the endoscopy, the satisfaction of the procedure concerning the amount of mucus and foam according to the performing endoscopist will be noted on a scale of 1-10.
Onderzoeksproduct en/of interventie
Timing of simethicone
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age of 18 years or older
- Scheduled for elective upper endoscopy with sedation
- Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Previous upper GI surgery precluding recognition and photodocumentation of anatomic landmarks.
- Achalasia
- Known stenosis of the upper GI tract
- Known gastroparesis
- Allergies to Simethicone
- Pregnancy
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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| Register | ID |
|---|---|
| NTR-new | NL8383 |
| Ander register | MECU-U : W19.228 |