Application of Simethicone in Esophagogastroscopy

Optimization of Simethicone Administration Strategy Before Esophagogastroscopy

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.

Study Overview

• Status: Completed
• 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

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.

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, PLA General Hospital

Publications and helpful links

General Publications

• Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone +/- N-acetylcysteine. Transl Gastroenterol Hepatol. 2018 May 19;3:29. doi: 10.21037/tgh.2018.05.02. eCollection 2018.
• Sun X, Xu Y, Zhang X, Ma C, Li A, Yu H, Zhang W, Zhang H, Yang T, Miao X, Zhang H, Liu Y, Lu Z. Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial. Trials. 2021 Aug 21;22(1):555. doi: 10.1186/s13063-021-05527-8.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: 307-simethicone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No