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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02310139
Registration number
NCT02310139
Ethics application status
Date submitted
3/12/2014
Date registered
5/12/2014
Date last updated
29/06/2023
Titles & IDs
Public title
Failed/Difficult Colonoscopy Outcomes
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Scientific title
Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre
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Secondary ID [1]
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HREC2014/9/4.7(4082)
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Universal Trial Number (UTN)
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Trial acronym
FoDCO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colonoscopy
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Failed/Difficult Colonoscopy - Patients referred for colonoscopy because of previously failed attempt at complete caecal intubation.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Description of reasons for failure of colonoscopy.
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Assessment method [1]
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Listing and making note of techniques used to perform successful and complete colonoscopy.
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Timepoint [1]
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60 days
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Eligibility
Key inclusion criteria
* Previously failed colonoscopy
* Referred to Westmead Endoscopy Unit for a complete colonoscopy
* 18 years or older
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Younger than 18 years
* Previously successful colonoscopy
* No previous colonoscopy attempted
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2023
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Sample size
Target
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Accrual to date
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Final
13
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital Endoscopy Unit - Sydney
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Recruitment postcode(s) [1]
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2145 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Professor Michael Bourke
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this removal is also known as polypectomy. Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a tertiary centre with extensive experience in difficult colonoscopy or have an alternative test such as CT scan. The investigators unit has accumulated significant experience related to previously failed colonoscopy and anecdotally appears to have a high success rate in completing the procedure. The purpose of this project is to describe the investigators technical approach to management of patients with previously failed colonoscopy. There is no additional intervention and the project is observational in nature. The investigators will collect data on patient characteristics, the reason for the failure and what technique was used to overcome the difficulty. The investigators will also note whether the final outcome of the technique had any impact on the overall management of the patient.
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Trial website
https://clinicaltrials.gov/study/NCT02310139
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael J Bourke, MBBS
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Address
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Western Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02310139
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