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Failed/Difficult Colonoscopy Outcomes (FoDCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310139
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

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.


Condition or disease Intervention/treatment
Colonoscopy Procedure: Colonoscopy

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre
Study Start Date : May 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Failed/Difficult Colonoscopy
Patients referred for colonoscopy because of previously failed attempt at complete caecal intubation.
Procedure: Colonoscopy



Primary Outcome Measures :
  1. Description of reasons for failure of colonoscopy. [ Time Frame: 60 days ]
    Listing and making note of techniques used to perform successful and complete colonoscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
For a small proportion of patients a complete colonoscopy is unsuccessful due to technical and physical reasons. This will be the study population which will be invited to participate in this study.
Criteria

Inclusion Criteria:

  • Previously failed colonoscopy
  • Referred to Westmead Endoscopy Unit for a complete colonoscopy
  • 18 years or older

Exclusion Criteria:

  • Younger than 18 years
  • Previously successful colonoscopy
  • No previous colonoscopy attempted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310139


Contacts
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Contact: Rebecca Sonson, BN 98455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au
Contact: Farzan F Bahin, MBBS 98455555 ext 56700 farzan.fahrtash@sydney.edu.au

Locations
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Australia, New South Wales
Westmead Hospital Endoscopy Unit Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    Rebecca.Sonson@health.nsw.gov.au   
Contact: Michael J Bourke, MBBS    98455555 ext 56700    bec2153@gmail.com   
Sponsors and Collaborators
Professor Michael Bourke
Investigators
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Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02310139    
Other Study ID Numbers: HREC2014/9/4.7(4082)
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019