NCT02310139

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

8.1 years

First QC Date

December 3, 2014

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Description of reasons for failure of colonoscopy.

    Listing and making note of techniques used to perform successful and complete colonoscopy.

    60 days

Study Arms (1)

Failed/Difficult Colonoscopy

Patients referred for colonoscopy because of previously failed attempt at complete caecal intubation.

Procedure: Colonoscopy

Interventions

ColonoscopyPROCEDURE
Failed/Difficult Colonoscopy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital Endoscopy Unit

Sydney, New South Wales, 2145, Australia

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Michael J Bourke, MBBS

    Western Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

May 1, 2015

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations