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Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy

A Feasibility Randomised Controlled Trial (RCT) of Contrast Enhanced vs Non-enhanced Colonscopy in Index Bowel Cancer Screening to Reduce Bowel Cancer Mortality

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01972451
Acronym
CONSCOP
Enrollment
1320
Registered
2013-10-30
Start date
2014-11-30
Completion date
2017-06-30
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

The Bowel Cancer Screening program was implemented to address the important issue of prevention and early detection of bowel cancer. Results from the first few years of screening and previous smaller studies show that while in its current form it will save many lives, there continue to be polyps and cancers in the upper large bowel (right side) that may be difficult to detect. There is some evidence that these types of polyps (serrated polyps) may be at least partly responsible for cancers missed at the initial colonoscopy and have a faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a safe food colouring agent base already used in various bowel camera procedures in standard clinical practice). This has been shown to improve detection of conventional polyps significantly even though it is considered by some to be more time consuming (possibly taking a few minutes longer) and requiring specific training to undertake. We hope to study the feasibility of undertaking these procedures to improve detection and removal of these polyps within the bowel screening program and potentially inform further studies to assess the impact of improved detection and consequent potentially reduced incidence of interval or missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study are to assess if this type of procedure would be feasible to implement and acceptable to participants, colonoscopists and the screening program and also assess any additional time or costs involved to inform the question of if a larger study should then be undertaken to conclusively prove or disprove the merits of this approach in terms of health economics, cancer detection and survival.

Interventions

PROCEDUREColonoscopy with enhanced dye

Sponsors

Lisette Nixon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All participants testing positive on Faecal Occult Blood Test (FOBT) in the screening program who are eligible and appropriate for an index screening colonoscopy will be offered participation in the study. * All participants attending for a one year surveillance colonoscopy if they have undergone an index screening colonoscopy as part of the study as per current guidelines for surveillance will also be offered inclusion

Exclusion criteria

* Any participants not deemed fit for colonoscopy on the screening program or undergoing alternative investigation such as CT Pneumocolon or minimal prep CT scan as their index procedure instead. * Participants who have undergone previous colorectal surgery will be excluded from the study though their standard management in the screening program will continue unchanged.

Design outcomes

Primary

MeasureTime frame
Procedure time and withdrawal time1 year

Secondary

MeasureTime frame
Number of people attending the screening1 year

Other

MeasureTime frame
Colonoscopy procedure completeness1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026