Trial Outcomes & Findings for Effect of Simethicone on Screening Colonoscopy (NCT NCT03119168)
NCT ID: NCT03119168
Last Updated: 2019-06-05
Results Overview
The number of adenomatous polyps removed at colonoscopy
COMPLETED
PHASE4
268 participants
25 minutes
2019-06-05
Participant Flow
Participant milestones
| Measure |
Simethicone Solution + Polyethylenglycol
This arm of the study will include the patients assigned to take simethicone solution with their colon preparation (4L Polyethylenglycol)
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus 4 L of polyethylenglycol
|
Polyethylenglycol
This arm of the study will include the patients assigned to take a regular bowel preparation with 4L Polyethylenglycol
Polyethylenglycol: All patients were assigned to take 4L polyethylenglycol as their regular bowel preparation
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
139
|
|
Overall Study
COMPLETED
|
129
|
139
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Simethicone on Screening Colonoscopy
Baseline characteristics by cohort
| Measure |
Simethicone Solution + Polyethylenglycol
n=129 Participants
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
|
Polyethylenglycol
n=139 Participants
This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol
Polyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 7.55 • n=99 Participants
|
57 years
STANDARD_DEVIATION 6.02 • n=107 Participants
|
57 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
111 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=99 Participants
|
139 participants
n=107 Participants
|
268 participants
n=206 Participants
|
|
Count of participants
|
129 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 25 minutesThe number of adenomatous polyps removed at colonoscopy
Outcome measures
| Measure |
Polyethylenglycol
n=139 Participants
The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope
|
Simethicone Solution + Polyethylenglycol
n=129 Participants
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
|
|---|---|---|
|
Adenoma Detection Rate
|
54 adenomas
|
43 adenomas
|
SECONDARY outcome
Timeframe: 6-10 minutesAmount spent withdrawing the scope during the colonoscopy
Outcome measures
| Measure |
Polyethylenglycol
n=139 Participants
The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope
|
Simethicone Solution + Polyethylenglycol
n=129 Participants
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
|
|---|---|---|
|
Withdrawal Times
|
399 seconds
Standard Deviation 76.7
|
395.7 seconds
Standard Deviation 69.2
|
SECONDARY outcome
Timeframe: 25 minutesBoston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent). Bubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor.
Outcome measures
| Measure |
Polyethylenglycol
n=139 Participants
The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope
|
Simethicone Solution + Polyethylenglycol
n=129 Participants
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
|
|---|---|---|
|
Colon Preparation
Boston Bowel Preparation Scale
|
8.9 score on a scale
Standard Deviation 0.4
|
8.9 score on a scale
Standard Deviation 0.4
|
|
Colon Preparation
Bubble Scale
|
2.1 score on a scale
Standard Deviation 2.1
|
0.1 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 6-10 minutesThe number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.
Outcome measures
| Measure |
Polyethylenglycol
n=139 Participants
The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope
|
Simethicone Solution + Polyethylenglycol
n=129 Participants
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
|
|---|---|---|
|
Intraprocedural Use of Simethicone
|
68 colonoscopies
|
2 colonoscopies
|
Adverse Events
Simethicone Solution + Polyethylenglycol
Polyethylenglycol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma
Texas Tech University Health Sciences Center at El Paso
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place