Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial

Conditions
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Gastric Mucosal Lesion

Intervention / Treatment
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* Drug: Simethicone
* Drug: Acetylcysteine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Group A - 100mL of water by mouth, 15 to 30 minutes before endoscopy | Other: Placebo<br>* 100mL of water<br>|
| Active Comparator: Simethicone<br>Group B - 100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy | Drug: Simethicone<br>* 100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy<br>* Other names: Aero-OM;|
| Active Comparator: Simethicone plus N-acetylcysteine<br>Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy | Drug: Acetylcysteine<br>* 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy<br>* Other names: Fluimucil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of mucosal visualization | Evaluation of the visibility of gastric mucosa during upper endoscopy using a scale (excelent, adequadate or inadequate) for esophagus, stomach and duodenum | 1 day (During endoscopy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Endoscopy, Gastric mucosa, Simethicone, Acetylcysteine