NCT03776916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 20, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

December 13, 2018

Last Update Submit

September 18, 2019

Conditions

Gastric Disease

Outcome Measures

Primary Outcomes (1)

  • Procedure time

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

    4 months

Secondary Outcomes (1)

  • Patients' satisfaction

    4 months

Study Arms (3)

Group 1

EXPERIMENTAL

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

Other: Simethicone administration 20-30 min before the procedure

Group 2

EXPERIMENTAL

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

Other: Simethicone administration 31-60 min before the procedure

Group 3

EXPERIMENTAL

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

Other: Simethicone administration > 60 min before the procedure

Interventions

Simethicone administration 20-30 min before the procedureOTHER

Patients intake simethicone 20-30 min before the procedure

Group 1
Simethicone administration 31-60 min before the procedureOTHER

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

Group 2
Simethicone administration > 60 min before the procedureOTHER

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

Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (2)

  • 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.

    PMID: 29971260BACKGROUND

  • 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.

    PMID: 34419109DERIVED

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yan Liu

    PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 17, 2018

Study Start

May 1, 2019

Primary Completion

July 31, 2019

Study Completion

August 31, 2019

Last Updated

September 20, 2019

Record last verified: 2019-05

Locations

CN(1)