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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre
Secondary ID [1] 0 0
HREC2014/9/4.7(4082)
Universal Trial Number (UTN)
Trial acronym
FoDCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Colonoscopy

Failed/Difficult Colonoscopy - Patients referred for colonoscopy because of previously failed attempt at complete caecal intubation.


Treatment: Surgery: Colonoscopy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Description of reasons for failure of colonoscopy.
Timepoint [1] 0 0
60 days

Eligibility
Key inclusion criteria
- Previously failed colonoscopy

- Referred to Westmead Endoscopy Unit for a complete colonoscopy

- 18 years or older
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Younger than 18 years

- Previously successful colonoscopy

- No previous colonoscopy attempted

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2023
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital Endoscopy Unit - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02310139
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02310139