Trial Outcomes & Findings for The Use of Narrow Band Imaging in Screening Colonoscopy (NCT NCT00908648)
NCT ID: NCT00908648
Last Updated: 2021-04-26
Results Overview
Detection of adenoma, defined as the number of patients with \> 1 adenoma, under White Light or NBI visualization
COMPLETED
NA
206 participants
duration of colonoscopy procedure
2021-04-26
Participant Flow
Gastroenterology Unit November 2007 - April 2008
Patients undergoing incomplete procedure for inadequate bowel cleansing or failure to reach the cecum were excluded from randomization
Participant milestones
| Measure |
Standard White Light
use of standard white light during the withdrawal phase of colonoscopy
|
Narrow Band Imaging
use of narrow band imaging during the withdrawal phase of colonoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
103
|
|
Overall Study
COMPLETED
|
108
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Narrow Band Imaging in Screening Colonoscopy
Baseline characteristics by cohort
| Measure |
Standard White Light
n=108 Participants
use of standard white light during the withdrawal phase of colonoscopy
|
Narrow Band Imaging
n=103 Participants
use of narrow band imaging during the withdrawal phase of colonoscopy
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: duration of colonoscopy procedureDetection of adenoma, defined as the number of patients with \> 1 adenoma, under White Light or NBI visualization
Outcome measures
| Measure |
Standard White Light
n=108 Participants
use of standard white light during the withdrawal phase of colonoscopy
|
Narrow Band Imaging
n=103 Participants
use of narrow band imaging during the withdrawal phase of colonoscopy
|
|---|---|---|
|
Adenoma Detection
|
63 participants
|
59 participants
|
SECONDARY outcome
Timeframe: duration of colonoscopy procedurenumber of patients with at least 1 flat and/or depressed adenoma
Outcome measures
| Measure |
Standard White Light
n=108 Participants
use of standard white light during the withdrawal phase of colonoscopy
|
Narrow Band Imaging
n=103 Participants
use of narrow band imaging during the withdrawal phase of colonoscopy
|
|---|---|---|
|
Detection of Flat and/or Depressed Adenomas
|
10 participants
|
22 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Vittorio Terruzzi, Director of Gastroenterology Unit
Gastroenterology Unit, Valduce Hospital - Como - Italy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place