Gastric DiseaseNCT03776916
Application of Simethicone in Esophagogastroscopy
A study testing Simethicone administration 20-30 min before the procedure, Simethicone administration 31-60 min before the procedure and Simethicone administration > 60 min before the procedure in people with Gastric Disease, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Disease
- What is being tested?
- Simethicone administration 20-30 min before the procedure, Simethicone administration 31-60 min before the procedure and Simethicone administration > 60 min before the procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years old patients
- Who agree to participate in the study
- Patients with the indications for gastroduodenoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Simethicone Administration Strategy Before 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.
Read the 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.
- Conditions
- Gastric Disease
- Being tested
- Simethicone administration 20-30 min before the procedure, Simethicone administration 31-60 min before the procedure, Simethicone administration > 60 min before the procedure
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone administration 20-30 min before the procedureOther
Patients intake simethicone 20-30 min before the procedure
Simethicone administration 31-60 min before the procedureOther
Patients intake simethicone administration 31-60 min before the procedure.
Simethicone administration > 60 min before the procedureOther
Patients intake simethicone administration > 60 min before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Simethicone administration 20-30 min before the procedure:
Patients intake simethicone solution 20-30 min before the procedure. Receives: 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. Receives: 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. Receives: Other: Simethicone administration > 60 min before the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
The time of examining the whole stomach was recorded, and the time for biopsy was not included.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 May 2019
- Primary completion31 Jul 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, Principal investigator, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776916
- Sponsor's protocol ID
- 307-simethicone
- Status last verified
- May 2019
- First submitted
- 13 Dec 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29971260Sun 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.
PubMed 34419109
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Simethicone Administration Strategy Before Esophagogastroscopy
- ClinicalTrials.gov ID
- NCT03776916
- Acronym / sponsor ID
- 307-simethicone
- Conditions
- Gastric Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Simethicone administration 20-30 min before the procedureSimethicone administration 20-30 min before the procedure: Patients intake simethicone solution 20-30 min before the procedure. |
| Group 2 | Experimental | Other: Simethicone administration 31-60 min before the procedureSimethicone administration 31-60 min before the procedure: Patients intake simethicone solution 31-60 min before the procedure. |
| Group 3 | Experimental | Other: Simethicone administration > 60 min before the procedureSimethicone administration >60 min before the procedure; Patients intake simethicone solution >60 min before the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years old patients
- Who agree to participate in the study
- Patients with the indications for gastroduodenoscopy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simethicone administration 20-30 min before the procedurePatients intake simethicone 20-30 min before the procedure | Other | Group 1 |
| Simethicone administration 31-60 min before the procedurePatients intake simethicone administration 31-60 min before the procedure. | Other | Group 2 |
| Simethicone administration > 60 min before the procedurePatients intake simethicone administration > 60 min before the procedure. | Other | Group 3 |
Primary outcome
Procedure time
Time frame: 4 months
The time of examining the whole stomach was recorded, and the time for biopsy was not included.
1 secondary outcome
Patients' satisfaction
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 29971260Sajid 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.
- Derived from this study: PubMed 34419109Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Liu principal investigator
PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simethicone administration 20-30 min before the procedure, Simethicone administration 31-60 min before the procedure and Simethicone administration > 60 min before the procedure in people with Gastric Disease, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776916, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.