Lesion of Stomach
Conditions
Keywords
simethicone, gastroscopy, McNalley score
Brief summary
A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.
Detailed description
Excessive bubbles or foam during gastroscopy is a common problem which can cause significant hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and contribute to poor patient tolerance during the scope. Simethicone, with or without N-acetylcysteine, has been extensively evaluated to improve mucosal visibility. However, the volume of simethicone preparation and the timing of ingesting this solution before gastroscope varied significantly across different studies. In general, it appeared that a larger volume of simethicone solution, given earlier before the gastroscopy, may yield better results. However, allowing a patient to ingest a large volume of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent Taiwanese study published in 2014 \[1\] showed that the subgroup with 100mg of simethicone in just 5ml of water, did achieve a good total mucosal visibility score, if the solution was ingested more than 30 minutes before the gastroscope. This may be because a longer time allows the simethicone to coat more of the mucosa. However, this study did not compare this preparation against a placebo. In Changi General Hospital, many gastroscopies are done daily with no premedication. Also, there is no protocol for premedication before gastroscopes. This study hopes to prove that a low volume of simethicone solution, given at an ample time (more than 30 minutes) before the scope, can significantly improve overall endoscopy performance compared to no premedication at all.
Interventions
DRUGSimethicone
100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
OTHERWater
5mls of water is given at least 30 minutes before the gastroscopy.
Sponsors
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned for an elective diagnostic gastroscopy by the attending gastroenterologist * Age of at least 21 years old * Mentally competent and able to provide informed consent
Exclusion criteria
* Category A patients (incarcerated prisoners) * adults who are unable to give their own informed consent due to lack of mental capacity * suspected gastrointestinal bleeding * suspected impacted foreign material * suspected gastric outlet obstruction * suspected esophageal obstruction * history of dysphagia * known hypersensitivity to simethicone * previous gastrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cumulative Mucosal Visibility Score | This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes. | Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured Total areas covered: (E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes. | * Area E: esophagus * Area D: duodenum * Area A: antrum and angularis * Area B: body and fundus Mc Nally score per area: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured |
| Volume of Additional Manual Flushes Required During Endoscopy in Mls | This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes. | The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles. |
| Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution | Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours | — |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Simethicone Premedication Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. | 27 |
| Placebo Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy. | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Placebo | Total | Simethicone Premedication |
|---|---|---|---|
| Age, Customized Age | 52.9 years STANDARD_DEVIATION 15.5 | 55.3 years STANDARD_DEVIATION 14 | 57.7 years STANDARD_DEVIATION 12.5 |
| Mean premedication time (min:sec) | 2468 seconds STANDARD_DEVIATION 596 | 2577 seconds STANDARD_DEVIATION 676 | 2686 seconds STANDARD_DEVIATION 756 |
| Region of Enrollment Singapore | 27 participants | 54 participants | 27 participants |
| Sex/Gender, Customized Female patients | 18 participants | 30 participants | 12 participants |
| Sex/Gender, Customized Male patients | 9 participants | 24 participants | 15 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Total Cumulative Mucosal Visibility Score
Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured Total areas covered: (E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus
Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simethicone Premedication | Total Cumulative Mucosal Visibility Score | 5.78 units | Standard Deviation 1.65 |
| Placebo | Total Cumulative Mucosal Visibility Score | 8.89 units | Standard Deviation 1.97 |
Secondary
Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution
Time frame: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simethicone Premedication | Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution | 0 number of events |
| Placebo | Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution | 0 number of events |
Secondary
Mucosal Visibility Score Per Area as Determined by Mc Nally Score:
* Area E: esophagus * Area D: duodenum * Area A: antrum and angularis * Area B: body and fundus Mc Nally score per area: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured
Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simethicone Premedication | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area A (antrum and angularis) | 1.30 units on a scale | Standard Deviation 0.54 |
| Simethicone Premedication | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area E (esopahgus) | 1.48 units on a scale | Standard Deviation 0.57 |
| Simethicone Premedication | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area B (body and fundus) | 1.74 units on a scale | Standard Deviation 0.81 |
| Simethicone Premedication | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area D (duodenum) | 1.26 units on a scale | Standard Deviation 0.53 |
| Placebo | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area B (body and fundus) | 2.44 units on a scale | Standard Deviation 0.97 |
| Placebo | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area D (duodenum) | 2.26 units on a scale | Standard Deviation 0.81 |
| Placebo | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area A (antrum and angularis) | 2.56 units on a scale | Standard Deviation 1.05 |
| Placebo | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: | Area E (esopahgus) | 1.59 units on a scale | Standard Deviation 0.57 |
Secondary
Volume of Additional Manual Flushes Required During Endoscopy in Mls
The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.
Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simethicone Premedication | Volume of Additional Manual Flushes Required During Endoscopy in Mls | 3.89 mls | Standard Deviation 11.46 |
| Placebo | Volume of Additional Manual Flushes Required During Endoscopy in Mls | 84.81 mls | Standard Deviation 110.18 |