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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

Tracking Information
First Submitted Date December 3, 2014
First Posted Date December 5, 2014
Last Update Posted Date July 5, 2019
Study Start Date May 2015
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2014)
Description of reasons for failure of colonoscopy. [ Time Frame: 60 days ]
Listing and making note of techniques used to perform successful and complete colonoscopy.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Failed/Difficult Colonoscopy Outcomes
Official Title Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Colonoscopy
Intervention Procedure: Colonoscopy
Study Groups/Cohorts Failed/Difficult Colonoscopy
Patients referred for colonoscopy because of previously failed attempt at complete caecal intubation.
Intervention: Procedure: Colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 4, 2014)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02310139
Other Study ID Numbers HREC2014/9/4.7(4082)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Professor Michael Bourke, Western Sydney Local Health District
Study Sponsor Professor Michael Bourke
Collaborators Not Provided
Investigators
Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District
PRS Account Western Sydney Local Health District
Verification Date July 2019