Failed/Difficult Colonoscopy Outcomes (FoDCO)

Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Procedure: Colonoscopy

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

• Study Contact: Name: Kathleen Goodrick, BN; Phone Number: 59779 98455555; Email: kathleen.goodrick@health.nsw.gov.au
• Study Contact Backup: Name: Farzan F Bahin, MBBS; Phone Number: 56700 98455555; Email: farzan.fahrtash@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Westmead Hospital Endoscopy Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of reasons for failure of colonoscopy.	Listing and making note of techniques used to perform successful and complete colonoscopy.	60 days

Collaborators and Investigators

• Sponsor: Professor Michael Bourke
• Investigators: Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimated): December 5, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HREC2014/9/4.7(4082)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No