Clinical trial NCT03776916: Application of Simethicone in Esophagogastroscopy
Official title: Optimization of Simethicone Administration Strategy Before Esophagogastroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Disease
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Procedure time
timeFrame: 4 months
Secondary outcomes:
measure: Patients' satisfaction
timeFrame: 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
affiliation: PLA General Hospital
name: Yan Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.