Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000120976
Ethics application status
Approved
Date submitted
27/11/2019
Date registered
10/02/2020
Date last updated
10/02/2020
Date data sharing statement initially provided
10/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Colorectal neoplasia(s) incidence in Bariatric Surgery Candidates
Scientific title
Evaluation of Colorectal neoplasia(s) incidence in Bariatric Surgery Candidates between different age groups.
Secondary ID [1] 299861 0
None
Universal Trial Number (UTN)
Trial acronym
BaSCoN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 315269 0
colorectal neoplasia 315270 0
colorectal cancer 315271 0
screening colonoscopy 315272 0
Condition category
Condition code
Diet and Nutrition 313569 313569 0 0
Obesity
Cancer 313570 313570 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colonoscopy will be performed to the patients who will be included in the study. All procedures will be held by the same team who contributes to this trial. Bowel cleansing will be achieved by polyethyleneglycol or a phosphate-based solution depending on the renal function. Colonoscopy will be performed under general anesthesia and 1-2 mg/kg propofol following premedication with midazolam 0.05 mg/kg and fentanyl 1 µg/kg. The procedure takes about 20 minutes. All polyps will be resected utilizing forceps or snares and will be sent for patholological examination. The same two pathologists will be responsible for the histologic examination. Polyp size will be measured in the laboratory and also colonoscopically, by comparison with a 6-mm forceps. Location of polyps will be recorded as proximal or distal with respect to the splenic flexure. Multiple polyps in both proximal and distal colon will be evaluated in diffuse category.
Intervention code [1] 316128 0
Early detection / Screening
Comparator / control treatment
The patients will be groupped according to their age. Group 1 will be consisted of patients aged 40-49 years while group 2 will be ?50 years of age. The surgeon will inform the patients about the colonoscopy and recommend the procedure prior to bariatric surgery.
Control group
Active

Outcomes
Primary outcome [1] 322025 0
Colorectal neoplasia incidence between different age groups.
Colorectal neoplasia will be assessed with the histopathologic evaluation of polyps.
Timepoint [1] 322025 0
2 years, post enrolment
Primary outcome [2] 322026 0
Colorectal cancer incidence between different age groups
Colorectal cancer diagnosis will be assessed with histopathologic examination of the polypectomy specimen.
Timepoint [2] 322026 0
2 years, post enrolment.
Secondary outcome [1] 377048 0
Classification of the detected colorectal neoplasia according to histopathology, location, size, multiplicity and Paris classification of colorectal polyps.
Timepoint [1] 377048 0
2 years, post enrolment

Eligibility
Key inclusion criteria
Bariatric surgery candidate, average-risk for colorectal cancer. Average risk defines asymptomatic individuals lacking high-risk medical conditions (polyposis syndromes, inflammatory bowel disease) and a personal/family history of CRN/CRCs.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had previous screening colonoscopy were excluded for standardization. Patients who were symptomatic (i.e.,bleeding, positive fecal occult blood test, changed bowel habits, iron deficiency anemia) or in "high-risk" category for colorectal cancer were also excluded as those who did not want to comply.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All statistics will be done using SPSS version 24.0 (Armonk, NY: IBM corp., USA). Continuous variables will be expressed as mean ± standard deviation. The incidence of CRNs and the
distribution of other variables in patients 40–49 years of age will be compared with the data obtained from patients who are ?equal or more than 50 years??? old. Chi-square test will be used to compare the categorical variables. Student’s t test will be used to compare the continuous variables. P < 0.05 will be regarded as statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 22132 0
Turkey
State/province [1] 22132 0
Istanbul

Funding & Sponsors
Funding source category [1] 304322 0
Self funded/Unfunded
Name [1] 304322 0
Country [1] 304322 0
Primary sponsor type
Individual
Name
Mehmet Ali Yerdel
Address
Istanbul Bariatrics, Obesity and Advanced Laparoscopy Center
Fulya Mahallesi, Polat Towerside, Yesilçimen Sokagi, Fulya Doktorlar No 12, 34343 Sisli/Istanbul
Country
Turkey
Secondary sponsor category [1] 304566 0
None
Name [1] 304566 0
Address [1] 304566 0
Country [1] 304566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304771 0
Acibadem University
Ethics committee address [1] 304771 0
Kayisdagi Caddesi No:32, 34752
Atasehir / Istanbul
Ethics committee country [1] 304771 0
Turkey
Date submitted for ethics approval [1] 304771 0
28/12/2018
Approval date [1] 304771 0
10/01/2019
Ethics approval number [1] 304771 0
2019-1/7

Summary
Brief summary
Even obesity and metabolic syndrome (MetS) are associated with colorectal neoplasia (CRN) and carcinoma (CRC), none of them is regarded as a criterion for the timing of first screening colonoscopy in guidelines. Incidences of CRNs in different age groups in bariatric surgery candidates will be compared by SC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98150 0
Prof Mehmet Ali Yerdel
Address 98150 0
Istanbul Bariatrics, Obesity and Advanced Laparoscopy Center
Fulya Mahallesi, Polat Towerside, Yesilçimen Sokagi, Fulya Doktorlar No 12, 34343 Sisli/Istanbul
Country 98150 0
Turkey
Phone 98150 0
+905323621081
Fax 98150 0
Email 98150 0
[email protected]
Contact person for public queries
Name 98151 0
Mehmet Ali Yerdel
Address 98151 0
Istanbul Bariatrics, Obesity and Advanced Laparoscopy Center
Fulya Mahallesi, Polat Towerside, Yesilçimen Sokagi, Fulya Doktorlar No 12, 34343 Sisli/Istanbul
Country 98151 0
Turkey
Phone 98151 0
+905323621081
Fax 98151 0
Email 98151 0
[email protected]
Contact person for scientific queries
Name 98152 0
Mehmet Ali Yerdel
Address 98152 0
Istanbul Bariatrics, Obesity and Advanced Laparoscopy Center
Fulya Mahallesi, Polat Towerside, Yesilçimen Sokagi, Fulya Doktorlar No 12, 34343 Sisli/Istanbul
Country 98152 0
Turkey
Phone 98152 0
+905323621081
Fax 98152 0
Email 98152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
e-mail: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.