Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY, United Kingdom
NCT Number: NCT02529007
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.
Looking for future studies?
Notify Me60 year–75 year
All sexes
Interventional
Not applicable
Portsmouth, Hampshire, PO6 3LY, United Kingdom
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colonoscopy performed with endo-cuff attached to the colonoscope
Standard colonoscopy without end-cuff
Time frame: 1 month (when pathology report available)
Time frame: 1 month (when pathology report available)
Time frame: 1 month (when pathology report available)
Time frame: 1 month (when pathology report available)
Time frame: 1 month (when pathology report available)
Time frame: 1 day
will be recorded at the time of the procedure
Time frame: 1 day
will be recorded at the time of the procedure
Time frame: 1 day
will be recorded at the time of the procedure
Time frame: 1 day
will be recorded at the time of the procedure
Time frame: 1 day
will be recorded at the time of the procedure
Portsmouth Hospitals NHS Trust
Other Gov
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
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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