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Application of Simethicone in Esophagogastroscopy

Primary Purpose

Gastric Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Simethicone administration 20-30 min before the procedure
Simethicone administration 31-60 min before the procedure
Simethicone administration > 60 min before the procedure
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 13, 2018
Last Updated
September 18, 2019
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03776916
Brief Title
Application of Simethicone in Esophagogastroscopy
Official Title
Optimization of Simethicone Administration Strategy Before Esophagogastroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Simethicone administration 20-30 min before the procedure: Patients intake simethicone solution 20-30 min before the procedure.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Simethicone administration 31-60 min before the procedure: Patients intake simethicone solution 31-60 min before the procedure.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Simethicone administration >60 min before the procedure; Patients intake simethicone solution >60 min before the procedure.
Intervention Type
Other
Intervention Name(s)
Simethicone administration 20-30 min before the procedure
Intervention Description
Patients intake simethicone 20-30 min before the procedure
Intervention Type
Other
Intervention Name(s)
Simethicone administration 31-60 min before the procedure
Intervention Description
Patients intake simethicone administration 31-60 min before the procedure.
Intervention Type
Other
Intervention Name(s)
Simethicone administration > 60 min before the procedure
Intervention Description
Patients intake simethicone administration > 60 min before the procedure.
Primary Outcome Measure Information:
Title
Procedure time
Description
The time of examining the whole stomach was recorded, and the time for biopsy was not included.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Patients' satisfaction
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu
Organizational Affiliation
PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29971260
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.
Results Reference
background
PubMed Identifier
34419109
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.
Results Reference
derived

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Application of Simethicone in Esophagogastroscopy

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