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Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening

NCT ID: NCT02529007

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

Detailed Description

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Problem statement:

In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.

Research question/hypothesis:

Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?

Study design:

Parallel group, single blinded randomised controlled trial

Study participants:

Patients attending for colonoscopy under the bowel cancer screening programme

Planned sample size: 534

Planned study period: 12 months

Primary objective:

To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient

Conditions

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Colonic Polyps Colonic Neoplasms

Keywords

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Colonoscopy early cancer detection cancer screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard

These patients have standard colonoscopy performed

Group Type ACTIVE_COMPARATOR

Standard colonoscopy

Intervention Type OTHER

Standard colonoscopy without end-cuff

Endocuff

These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope

Group Type EXPERIMENTAL

Endo-cuff

Intervention Type DEVICE

Colonoscopy performed with endo-cuff attached to the colonoscope

Interventions

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Endo-cuff

Colonoscopy performed with endo-cuff attached to the colonoscope

Intervention Type DEVICE

Standard colonoscopy

Standard colonoscopy without end-cuff

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients referred for colonoscopy under the national bowel cancer screening programme
* Able to provide written informed consent

Exclusion Criteria

* History of Inflammatory bowel disease
* History of Hereditary non polyposis colorectal cancer
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pradeep Bhandari, MBBS, MD, MRCP

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

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Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Bhattacharyya R, Chedgy F, Kandiah K, Fogg C, Higgins B, Haysom-Newport B, Gadeke L, Thursby-Pelham F, Ellis R, Goggin P, Longcroft-Wheaton G, Bhandari P. Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial. Endoscopy. 2017 Nov;49(11):1043-1050. doi: 10.1055/s-0043-111718. Epub 2017 Jun 14.

Reference Type DERIVED
PMID: 28614895 (View on PubMed)

Other Identifiers

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PHT/2013/71

Identifier Type: -

Identifier Source: org_study_id