Gastric Mucosal Lesion Clinical Trial
Official title:
Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial
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.
a. Study type: prospective, randomized, double-blinded, placebo-controlled trial: i.
Prospective inclusion of patients; ii. Randomization by computer generated tables; iii.
Allocation concealment by sealed, opaque envelopes; iv. Double-blinded - nurse instructed
not to reveal treatment; patient and doctor unaware of treatment;
b. Patient selection: consecutive series of patients scheduled for upper gastrointestinal
endoscopy; Exclusion criteria - sedation, previous total gastrectomy, known neoplasia or
stenosis, allergies to simethicone or N-acetylcysteine, therapeutic or urgent procedures;
c. Sample size: 270 (3 groups of 90 patients): to improve "excellent" preparations from 20%
(value from our own database) to 40% and assuming a normal distribution and a power of 80%
(α=0.05), the calculated sample size of each of the 3 groups was 82; allowing for a 10%
dropout rate, the sample size is 90 (270 patients overall); Groups: Group A - 100mL of water
(placebo); Group B - 100mL of water plus 100mg Simethicone; Group C - 100mL of water plus
100mg Simethicone plus 600mg N-acetylcysteine;
d. Data collection methods: form sheet filled by nurses (appendix 1) and endoscopist
(appendix 2);
e. Analysed variables: patients characteristics (age, gender), indication for endoscopy,
time from administration to procedure, score of mucosal visualization, side effects of
medication;
f. Statistical analysis: chi-square test.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic