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Completed

NCT Number: NCT02529007

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endo-cuff

Device

Colonoscopy performed with endo-cuff attached to the colonoscope

Standard colonoscopy

Other

Standard colonoscopy without end-cuff

Primary outcomes

  1. Number of polyps detected per patient

    Time frame: 1 month (when pathology report available)

Secondary outcomes

  1. Cancer detection rate

    Time frame: 1 month (when pathology report available)

  2. Polyp detection rate

    Time frame: 1 month (when pathology report available)

  3. Adenomas per patient

    Time frame: 1 month (when pathology report available)

  4. Adenoma detection rate

    Time frame: 1 month (when pathology report available)

  5. Caecal intubation rate

    Time frame: 1 day

    will be recorded at the time of the procedure

  6. Total procedure time - from scope insertion to removal

    Time frame: 1 day

    will be recorded at the time of the procedure

  7. Time taken to reach caecum

    Time frame: 1 day

    will be recorded at the time of the procedure

  8. Time taken to withdraw scope (from caecum to removal of scope)

    Time frame: 1 day

    will be recorded at the time of the procedure

  9. Patient comfort score

    Time frame: 1 day

    will be recorded at the time of the procedure

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Official study title

Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study

Acronym: E-CAP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2015
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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