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临床试验/NCT03776916
NCT03776916已完成不适用

Optimization of Simethicone Administration Strategy Before Esophagogastroscopy

Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
311
试验地点
1
主要终点
Procedure time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 18 years old patients
  • Who agree to participate in the study
  • Patients with the indications for gastroduodenoscopy

排除标准

  • 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

研究组 & 干预措施

Group 1

Experimental

Simethicone administration 20-30 min before the procedure:

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

干预措施: Simethicone administration 20-30 min before the procedure (Other)

Group 2

Experimental

Simethicone administration 31-60 min before the procedure:

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

干预措施: Simethicone administration 31-60 min before the procedure (Other)

Group 3

Experimental

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

干预措施: Simethicone administration > 60 min before the procedure (Other)

结局指标

主要结局

Procedure time

时间窗: 4 months

The time of examining the whole stomach was recorded, and the time for biopsy was not included.

次要结局

  • Patients' satisfaction(4 months)

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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