Clinical trial NCT02529007: Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
Official title: Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Colonic Neoplasms
Keywords: Colonoscopy
early cancer detection
cancer screening
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2015-08-19
Enrollment: 534
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of polyps detected per patient
timeFrame: 1 month (when pathology report available)
Secondary outcomes:
measure: Cancer detection rate
timeFrame: 1 month (when pathology report available)
measure: Polyp detection rate
timeFrame: 1 month (when pathology report available)
measure: Adenomas per patient
timeFrame: 1 month (when pathology report available)
measure: Adenoma detection rate
timeFrame: 1 month (when pathology report available)
measure: Caecal intubation rate
timeFrame: 1 day
measure: Total procedure time - from scope insertion to removal
timeFrame: 1 day
measure: Time taken to reach caecum
timeFrame: 1 day
measure: Time taken to withdraw scope (from caecum to removal of scope)
timeFrame: 1 day
measure: Patient comfort score
timeFrame: 1 day
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Pradeep Bhandari, MBBS, MD, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.