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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

206 participants

Primary outcome timeframe

duration of colonoscopy procedure

Results posted on

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

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

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 procedure

Detection of adenoma, defined as the number of patients with \> 1 adenoma, under White Light or NBI visualization

Outcome measures

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 procedure

number of patients with at least 1 flat and/or depressed adenoma

Outcome measures

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

Phone: +39031324009

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place