Skip to content

Application of Simethicone in Esophagogastroscopy

Optimization of Simethicone Administration Strategy Before Esophagogastroscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03776916
Enrollment
311
Registered
2018-12-17
Start date
2019-05-01
Completion date
2019-08-31
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Disease

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.

Interventions

OTHERSimethicone administration 20-30 min before the procedure

Patients intake simethicone 20-30 min before the procedure

OTHERSimethicone administration 31-60 min before the procedure

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

OTHERSimethicone administration > 60 min before the procedure

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

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Procedure time4 monthsThe time of examining the whole stomach was recorded, and the time for biopsy was not included.

Secondary

MeasureTime frameDescription
Patients' satisfaction4 monthsA 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026