Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000456055
Ethics application status
Approved
Date submitted
27/05/2010
Date registered
4/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Narrow-band imaging compared with conventional colonoscopy for the detection of colorectal polyps in adults: a randomized controlled trial.
Scientific title
Narrow-band imaging compared with conventional colonoscopy for the detection of colorectal polyps in adults: a randomized controlled trial.
Secondary ID [1] 890 0
LATIN AMERICAN CLINICAL TRIAL REGISTRY: LATINREC-COL077
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal polyps are common and usually benign and produce no symptoms. There may be single or multiple polyps and they become more common as people age. There is some evidence that most cancers develop from polyps, particularly from adenomatous polyps; therefore, detection and eradication strategies for polyps are important. In most cases, the polyps may be removed at the same time a colonoscopy is performed. 236915 0
Condition category
Condition code
Oral and Gastrointestinal 237273 237273 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the first part of the procedure the colonoscope is inserted through the rectum and advanced to the large intestine, using conventional colonoscopy in both groups for detecting lesions. Thereafter, patients will be randomly assigned to colonoscope withdrawal using either conventional wide-angle (approximately 10 minutes) or narrow-band imaging (NBI) technology. The colonoscopies will be performed using High Definition monitors. Appropriate and complete bowel preparation before colonoscopy will be ensured using four liters of polyethylene glycol lavage until clear rectal fluid will be evacuated as well as cleaning enema
Intervention code [1] 256566 0
Diagnosis / Prognosis
Comparator / control treatment
The narrow-band imaging (NBI) technology in conventional video colonoscopes uses special filters to narrow a light source, eliminating red, enhancing structures and rendering vascular structures in black (approximately 10 minutes).
Control group
Active

Outcomes
Primary outcome [1] 258532 0
Mean number of polyps per patient assessed by one endoscopist
Timepoint [1] 258532 0
During procedure
Primary outcome [2] 258557 0
Total number of detected polyps assessed by one endoscopist
Timepoint [2] 258557 0
During procedure
Secondary outcome [1] 264366 0
Total size of detected polyps
Timepoint [1] 264366 0
During the procedure assessed by one endoscopist
Secondary outcome [2] 264410 0
Site of polyp detection
Timepoint [2] 264410 0
During procedure assessed by one endoscopist
Secondary outcome [3] 264411 0
Colonoscopy Time
Timepoint [3] 264411 0
During the procedure assessed by one endoscopist
Secondary outcome [4] 264412 0
Colonoscopy Time to first detected polyp
Timepoint [4] 264412 0
During the procedure assessed by one endoscopist
Secondary outcome [5] 264413 0
Polyps characteristics
Timepoint [5] 264413 0
During the procedure assessed by one endoscopist
Secondary outcome [6] 264414 0
Adverse events (i.e. perforation)
Timepoint [6] 264414 0
During the procedure assessed by one endoscopist
Secondary outcome [7] 264415 0
Bleeding Number of removed polyps
Timepoint [7] 264415 0
During the procedure assessed by one endoscopist
Secondary outcome [8] 264416 0
Biopsy findings
Timepoint [8] 264416 0
During the procedure assessed by one endoscopist

Eligibility
Key inclusion criteria
Patients aged 18 years or above with clinical indications for colonoscopy are eligible to enter this trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous colorectal surgery - Patients with significant family history: Hereditary nonpolyposis colorectal cancer Colorectal cancer or adenomatous polyps in a first-degree relative younger than 60 years, or in two or more first-degree relatives of any age, - Pregnant women - When the risks to patient health or life are judged to outweigh the most favorable benefits of the procedure - When adequate patient cooperation or consent cannot be obtained - When a perforated viscus is known or suspected - Fulminant colitis - Documented acute diverticulitis - Upper GI bleeding or melena with a demonstrated upper gastro intestinal (GI) source - Acute Low GI bleeding - Previous colonoscopy in the last 24 months - Acute diarrhea - Incomplete bowel-cleansing preparation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed randomization envelopes are provided and are held centrally at each investigational site. An envelope is opened when a patient agrees to take part and when the endoscopist will begin to retrieve the colonoscope from the cecum.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a multicentre, open-label, randomized, parallel-group study. The study will enroll consecutive patients who will underwent colonoscopy using a conventional colonoscope at the Reina Sofía Clinic and Colombia Clinic in Bogota, Colombia. During the first part of the procedure the colonoscope is inserted through the rectum and advanced to the large intestine, using conventional colonoscopy in both groups for detecting lesions. When the colonoscope will begin to be retrieved from the cecum, patients will be randomized to conventional colonoscopy or the NBI system colonoscopy. A computer random list was used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment outside Australia
Country [1] 1826 0
Colombia
State/province [1] 1826 0
Bogota

Funding & Sponsors
Funding source category [1] 257063 0
University
Name [1] 257063 0
Instituto de Investigaciones, Fundacion Universitaria Sanitas
Country [1] 257063 0
Colombia
Primary sponsor type
University
Name
Instituto de Investigaciones, Fundacion Universitaria Sanitas
Address
Av. Cra 68 no. 22A – 30, Bogota, Colombia
Country
Colombia
Secondary sponsor category [1] 256317 0
None
Name [1] 256317 0
Address [1] 256317 0
Country [1] 256317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259087 0
Comite de etica medica, Fundacion Universitaria Sanitas
Ethics committee address [1] 259087 0
Instituto de Investigaciones, Fundacion Universitaria Sanitas
Av. Cra 68 no. 22A - 30 Bogota
Ethics committee country [1] 259087 0
Colombia
Date submitted for ethics approval [1] 259087 0
10/09/2007
Approval date [1] 259087 0
01/11/2007
Ethics approval number [1] 259087 0

Summary
Brief summary
This is a multicentre, open-label, randomized, parallel-group study. The study will enroll consecutive patients who will underwent colonoscopy using a conventional colonoscope at the Reina Sofia Clinic and Colombia Clinic in Bogota, Colombia. During the first part of the procedure the colonoscope is inserted through the rectum and advanced to the large intestine, using conventional colonoscopy in both groups for detecting lesions. When the colonoscope will begin to be retrieved from the cecum, patients will be randomized to conventional colonoscopy or the NBI system colonoscopy. Sealed randomization envelopes are provided and are held centrally at each investigational site. An envelope is opened when a patient agrees to take part and when the endoscopist will begin to retrieve the colonoscope from the cecum.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 29694 0
Address 29694 0
Country 29694 0
Phone 29694 0
Fax 29694 0
Email 29694 0
Contact person for public queries
Name 12941 0
Ludovic Reveiz
Address 12941 0
Avenida Calle 127 # 21 - 60 cons 221, Bogota
Country 12941 0
Colombia
Phone 12941 0
57 1 6252166
Fax 12941 0
Email 12941 0
mmreveiz@hotmail.com
Contact person for scientific queries
Name 3869 0
Ludovic Reveiz
Address 3869 0
Avenida Calle 127 # 21 - 60 cons 221, Bogota
Country 3869 0
Colombia
Phone 3869 0
57 1 6252166
Fax 3869 0
Email 3869 0
mmreveiz@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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