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OpenTrials
Completed

NCT Number: NCT03776916

Application of Simethicone in Esophagogastroscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PLA General Hospital

Beijing, Beijing Municipality, 100071, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simethicone administration 20-30 min before the procedure

Other

Patients intake simethicone 20-30 min before the procedure

Simethicone administration 31-60 min before the procedure

Other

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

Simethicone administration > 60 min before the procedure

Other

Patients intake simethicone administration > 60 min before the procedure.

Primary outcomes

  1. Procedure time

    Time frame: 4 months

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

Secondary outcomes

  1. Patients' satisfaction

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Other

Registry information

Official study title

Optimization of Simethicone Administration Strategy Before Esophagogastroscopy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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