Trial Outcomes & Findings for L-Menthol Injection as a Novel Technique During Colonoscopy (NCT NCT02588248)
NCT ID: NCT02588248
Last Updated: 2022-04-19
Results Overview
Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
82 participants
Primary outcome timeframe
2 weeks
Results posted on
2022-04-19
Participant Flow
Day1 - patients undergoing screening and surveillance colonoscopy are pre-screened to evaluate if they meet inclusion criteria. Once identified patient is approached by study personnel to determine their willingness. If willing to participate will undergo written consent for participation. Patients will be followed up by telephone for adverse reactions at 24-48 hr, one week and one month after colonoscopy.
Patients will be questioned regarding their allergy status specific to peppermint oil and this will be documented in the consent form and in the RedCap database. The patient must meet all inclusion and exclusion criteria and willing to participate in informed consent.
Participant milestones
| Measure |
Placebo
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose =80 ml Solution B which contains 0 mg of L-Menthol).
|
Peppermint Oil
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
|
Overall Study
COMPLETED
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose =80 ml Solution B which contains 0 mg of L-Menthol).
|
Peppermint Oil
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; with 0 mg of L-Methol).
|
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=38 Participants
|
30 Participants
n=37 Participants
|
58 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=38 Participants
|
7 Participants
n=37 Participants
|
17 Participants
n=75 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 6.75 • n=38 Participants
|
67.73 years
STANDARD_DEVIATION 8.8 • n=37 Participants
|
60.5 years
STANDARD_DEVIATION 7.77 • n=75 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=38 Participants
|
25 Participants
n=37 Participants
|
46 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=38 Participants
|
12 Participants
n=37 Participants
|
29 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
38 Participants
n=38 Participants
|
37 Participants
n=37 Participants
|
75 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: 2 weeksEvaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Outcome measures
| Measure |
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
|
|---|---|---|
|
Adenoma Detection Rates
Adenoma Detected "Yes" Yes Adenoma Detected
|
19 Participants
|
20 Participants
|
|
Adenoma Detection Rates
Adenoma Detected "No"
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 week .Evaluate for changes in Polyp detection rates.
Outcome measures
| Measure |
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
|
|---|---|---|
|
Polyp Detection Rates
Polyp detected "Yes"
|
30 Participants
|
29 Participants
|
|
Polyp Detection Rates
Polyp detected "No"
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: immediatePopulation: Note that total procedure time was not collected
Evaluate for changes in total procedure time, cecal intubation time, and withdrawal time with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Outcome measures
| Measure |
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
|
|---|---|---|
|
Procedure Time
Withdraw Time in minutes
|
20.5 minutes
Interval 6.1 to 31.2
|
17.2 minutes
Interval 0.5 to 42.7
|
|
Procedure Time
Cecal Intubation time in minutes
|
12.4 minutes
Interval 4.1 to 46.7
|
12.9 minutes
Interval 3.9 to 22.8
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The data was not entered in the database in a format that would allow it to be collated according to the definition above. Also, some subjects did show more than one advanced adenoma.
Evaluate for changes in advanced adenoma detection rates with the use of intraluminal peppermint oil application vs placebo during coloscopy. Advanced adenoma will be define as an adenoma with significant villous features (\>25%), size of 1.0 cm or more, high-grade dysplasia, or early invasive cancer.
Outcome measures
| Measure |
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
|
|---|---|---|
|
Advanced Adenoma Detection Rates
Tubular Adenoma
|
19 participants
|
19 participants
|
|
Advanced Adenoma Detection Rates
Tubulovillous Adenoma
|
0 participants
|
0 participants
|
|
Advanced Adenoma Detection Rates
Villous Adenoma
|
0 participants
|
0 participants
|
|
Advanced Adenoma Detection Rates
Serrated Adenoma
|
1 participants
|
4 participants
|
|
Advanced Adenoma Detection Rates
Cancer
|
1 participants
|
1 participants
|
|
Advanced Adenoma Detection Rates
No Adenoma
|
18 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 2 weeksEvaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy.
Outcome measures
| Measure |
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
|
|---|---|---|
|
Cancer Detection Rates
Cancer detected "Yes"
|
1 Participants
|
1 Participants
|
|
Cancer Detection Rates
Cancer detected "No"
|
36 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 1 dayEvaluate for changes in reported patient comfort levels with the use of intraluminal peppermint oil application vs placebo during colonoscopy.
Outcome measures
| Measure |
Peppermint Oil
n=37 Participants
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
|
Placebo
n=38 Participants
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
|
|---|---|---|
|
Patient Comfort Level Recorded on Post-procedure Survey
No Discomfort
|
17 Participants
|
19 Participants
|
|
Patient Comfort Level Recorded on Post-procedure Survey
Slight Discomfort
|
15 Participants
|
15 Participants
|
|
Patient Comfort Level Recorded on Post-procedure Survey
Moderate(bothersome)
|
5 Participants
|
1 Participants
|
|
Patient Comfort Level Recorded on Post-procedure Survey
Severe
|
0 Participants
|
0 Participants
|
|
Patient Comfort Level Recorded on Post-procedure Survey
Not available
|
0 Participants
|
3 Participants
|
Adverse Events
Peppermint Oil
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peppermint Oil
n=37 participants at risk
Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone
Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).
|
Placebo
n=38 participants at risk
Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).
|
|---|---|---|
|
Gastrointestinal disorders
bloating and cramping
|
2.7%
1/37 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
10.5%
4/38 • Number of events 4 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
Loss of appetite
|
2.7%
1/37 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
0.00%
0/38 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
cramping
|
2.7%
1/37 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
5.3%
2/38 • Number of events 2 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
bloating
|
5.4%
2/37 • Number of events 2 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
0.00%
0/38 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Skin and subcutaneous tissue disorders
bumps
|
2.7%
1/37 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
0.00%
0/38 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
constipation and bloating
|
0.00%
0/37 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
2.6%
1/38 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/37 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
2.6%
1/38 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/37 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
2.6%
1/38 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
|
Gastrointestinal disorders
hemorrhoids
|
2.7%
1/37 • Number of events 1 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
0.00%
0/38 • Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
|
Additional Information
L-Menthol Injection as a Novel Technique during Colonoscopy: The MINT-C study
UHClevelandMC
Phone: 216-844-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place