Application of Simethicone in Esophagogastroscopy

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial to comparing the different simethicone administration strategies for esophagogastroscopy. Recent studies have indicated that the administration of simethicone before endoscopic examination could shorten the procedure time and improve the diagnostic rate of the gastric mucosal lesions. But the time interval between simethicone administration and the examination has not been fully determined. This study will test whether the time of taking simethicone before endoscopy could influence the performance of the procedure in a randomized controlled trial. The results may benefit the current clinical practice.

Detailed Description
-----------------
Esophagogastroscopy can enable the direct examination of the esophageal and gastric mucosal lesions, which has been widely applied in clinical practice. However, during the examination, too much water, foam or residues in the stomach will not only increase the procedure time and the misdiagnosis rate, but also decrease the patients' tolerance, for more efforts should be made to deal with the excessive water, foam or residues in order to obtain a clear view of the mucosa. Simethicone is also called poly-dimethylsiloxane, which can be used to remove the foam and water. Although simethicone has been routinely administrated before the esophagogastroscopy, the optimal strategy of administrating simethicone has not been clearly investigated, especially the time to administrate simethicone. Intaking simethicone too early will result in too excessive water in the stomach, while if the patients take it too late it doesn't take effects. Thus, this is a study to determine whether selecting different simethicone administration strategies could improve the performance of the esophagogastroscopy and minimize the patients' dissatisfaction.

Official Title
-----------------
Optimization of Simethicone Administration Strategy Before Esophagogastroscopy

Conditions
-----------------
Gastric Disease

Intervention / Treatment
-----------------
* Other: Simethicone administration 20-30 min before the procedure
* Other: Simethicone administration 31-60 min before the procedure
* Other: Simethicone administration > 60 min before the procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years old patients Who agree to participate in the study Patients with the indications for gastroduodenoscopy Exclusion Criteria: Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks. Severe uncontrolled coagulopathy Prior history of gastric surgery. Pregnancy and lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Simethicone administration 20-30 min before the procedure: Patients intake simethicone solution 20-30 min before the procedure. | Other: Simethicone administration 20-30 min before the procedure<br>* Patients intake simethicone 20-30 min before the procedure<br>|
| Experimental: Group 2<br>Simethicone administration 31-60 min before the procedure: Patients intake simethicone solution 31-60 min before the procedure. | Other: Simethicone administration 31-60 min before the procedure<br>* Patients intake simethicone administration 31-60 min before the procedure.<br>|
| Experimental: Group 3<br>Simethicone administration >60 min before the procedure; Patients intake simethicone solution >60 min before the procedure. | Other: Simethicone administration > 60 min before the procedure<br>* Patients intake simethicone administration > 60 min before the procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | The time of examining the whole stomach was recorded, and the time for biopsy was not included. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction | A 10-point scale was used to evaluate the patients' satisfaction (0 worst, 10 best). All the symptoms such as abdominal pain, distension and the like were all recorded. It is anticipated that the use of simethicone will significantly improve patients' satisfaction. | 4 months |