Application of Simethicone in Esophagogastroscopy

Gastric Disease Clinical Trial

Official title:

Optimization of Simethicone Administration Strategy Before Esophagogastroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776916
• Other study ID #: 307-simethicone
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: May 2019
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: August 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Disease
• Stomach Diseases

Intervention

Other:
• Simethicone administration 20-30 min before the procedure
Patients intake simethicone 20-30 min before the procedure
• Simethicone administration 31-60 min before the procedure
Patients intake simethicone administration 31-60 min before the procedure.
• Simethicone administration > 60 min before the procedure
Patients intake simethicone administration > 60 min before the procedure.

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure time	The time of examining the whole stomach was recorded, and the time for biopsy was not included.	4 months
Secondary	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