Trial Outcomes & Findings for Impacts of Inspection During Instrument Insertion on Colonoscopy Quality (NCT NCT03444090)
NCT ID: NCT03444090
Last Updated: 2019-05-09
Results Overview
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
428 participants
Primary outcome timeframe
During procedure, approximately one hour
Results posted on
2019-05-09
Participant Flow
Participant milestones
| Measure |
Insertion/Withdrawal Colon Polypectomy
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size \<10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size \>10 mm will be performed only during withdrawal of the scope.
|
Withdrawal Colon Polypectomy
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
214
|
|
Overall Study
COMPLETED
|
211
|
210
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impacts of Inspection During Instrument Insertion on Colonoscopy Quality
Baseline characteristics by cohort
| Measure |
Insertion/Withdrawal Colon Polypectomy
n=211 Participants
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size \<10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size \>10 mm will be performed only during withdrawal of the scope.
|
Withdrawal Colon Polypectomy
n=210 Participants
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
|
Total
n=421 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
211 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
211 participants
n=5 Participants
|
210 participants
n=7 Participants
|
421 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During procedure, approximately one hourColon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
Outcome measures
| Measure |
Insertion/Withdrawal Colon Polypectomy
n=211 Participants
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size \<10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size \>10 mm will be performed only during withdrawal of the scope.
|
Withdrawal Colon Polypectomy
n=210 Participants
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
|
|---|---|---|
|
Percentage of Participants With Detection of at Least One Adenoma Per Procedure
|
63.7 percentage of participants
Interval 56.6 to 70.0
|
68.1 percentage of participants
Interval 61.3 to 74.3
|
SECONDARY outcome
Timeframe: During procedure, approximately one hourMean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.
Outcome measures
| Measure |
Insertion/Withdrawal Colon Polypectomy
n=211 Participants
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size \<10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size \>10 mm will be performed only during withdrawal of the scope.
|
Withdrawal Colon Polypectomy
n=210 Participants
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
|
|---|---|---|
|
Mean Colon Adenoma Per Colonoscopy
|
1.6 adenomas/colonoscopy
Standard Deviation 2.0
|
1.9 adenomas/colonoscopy
Standard Deviation 2.4
|
Adverse Events
Insertion/Withdrawal Colon Polypectomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Withdrawal Colon Polypectomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chi-Liang Cheng
Evergreen General Hospital, Taoyuan, Taiwan
Phone: +886-3-4631230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place