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Randomised controlled trial of contrast-enhanced colonoscopy in the reduction of right-sided bowel cancer

Randomised controlled trial of contrast-enhanced colonoscopy in the reduction of right-sided bowel cancer (the CONSCOP 2 study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98539180
Enrollment
2652
Registered
2020-02-19
Start date
2021-07-23
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Bowel cancer Cancer

Interventions

A randomised open controlled trial (RCT) of chromocolonoscopy (spraying blue indigo carmine dye throughout the upper large bowel during colonoscopy) vs a standard colonoscopy without dye in index bowe

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All FIT-positive people in the participating centres, eligible for index screening colonoscopy using high definition scopes

Exclusion criteria

Exclusion criteria: 1. Previous resectional colorectal surgery (as this would influence both study methods and outcomes depending on the length of residual colon in the individual) 2. Known allergy to food colouring agent (as the Indigo Carmine dye is a safe food colouring agent but extremely rarely there may be individuals with a specific allergic response to this in the past)

Design outcomes

Primary

MeasureTime frame
Detection of any proximal advanced serrated lesions as defined by pathological assessment at index colonoscopy (colonoscopy intervention)

Secondary

MeasureTime frame
1. Pathological types and counts of all polyps detected at index procedure (colonoscopy intervention) 2. Pathological types and counts of all polyps detected at surveillance procedure (up to 1 year after repeat procedures). Types of all polyps detected at surveillance procedures will be obtained from local histopathology reports and routinely collected screening datasets 3. Cancers and deaths obtained from routinely collected health datasets (follow up for 3 years)

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactGeorgina Gardner
CONSCOP2@cardiff.ac.uk+44 (0)2920 687 950

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026