Application of Simethicone in Esophagogastroscopy

NCT ID: NCT03776916

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2019-08-31

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.

Conditions

Gastric Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Simethicone administration 20-30 min before the procedure:

Patients intake simethicone solution 20-30 min before the procedure.

Group Type: EXPERIMENTAL

Simethicone administration 20-30 min before the procedure

Intervention Type: OTHER

Patients intake simethicone 20-30 min before the procedure

Group 2

Simethicone administration 31-60 min before the procedure:

Patients intake simethicone solution 31-60 min before the procedure.

Group Type: EXPERIMENTAL

Simethicone administration 31-60 min before the procedure

Intervention Type: OTHER

Patients intake simethicone administration 31-60 min before the procedure.

Group 3

Simethicone administration \>60 min before the procedure; Patients intake simethicone solution \>60 min before the procedure.

Group Type: EXPERIMENTAL

Simethicone administration > 60 min before the procedure

Intervention Type: OTHER

Patients intake simethicone administration \> 60 min before the procedure.

Interventions

Simethicone administration 20-30 min before the procedure

Patients intake simethicone 20-30 min before the procedure

Intervention Type: OTHER

Simethicone administration 31-60 min before the procedure

Patients intake simethicone administration 31-60 min before the procedure.

Intervention Type: OTHER

Simethicone administration > 60 min before the procedure

Patients intake simethicone administration \> 60 min before the procedure.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Liu

Role: PRINCIPAL_INVESTIGATOR

PLA General Hospital

Locations

PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 29971260 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34419109 (View on PubMed)

Other Identifiers

307-simethicone

Identifier Type: -

Identifier Source: org_study_id