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

Sponsor

Portsmouth Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02529007

Collaborator

(none)

534

Enrollment

Location

Arms

Duration (Months)

44.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps Colonic Neoplasms	Device: Endo-cuff Other: Standard colonoscopy	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

534 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

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 Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard These patients have standard colonoscopy performed	Other: Standard colonoscopy Standard colonoscopy without end-cuff
Experimental: Endocuff These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope	Device: Endo-cuff Colonoscopy performed with endo-cuff attached to the colonoscope

Arm

Intervention/Treatment

Active Comparator: Standard

These patients have standard colonoscopy performed

Other: Standard colonoscopy

Standard colonoscopy without end-cuff

Experimental: Endocuff

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

Device: Endo-cuff

Colonoscopy performed with endo-cuff attached to the colonoscope

Outcome Measures

Primary Outcome Measures

Number of polyps detected per patient [1 month (when pathology report available)]

Secondary Outcome Measures

Cancer detection rate [1 month (when pathology report available)]
Polyp detection rate [1 month (when pathology report available)]
Adenomas per patient [1 month (when pathology report available)]
Adenoma detection rate [1 month (when pathology report available)]
Caecal intubation rate [1 day]
will be recorded at the time of the procedure
Total procedure time - from scope insertion to removal [1 day]
will be recorded at the time of the procedure
Time taken to reach caecum [1 day]
will be recorded at the time of the procedure
Time taken to withdraw scope (from caecum to removal of scope) [1 day]
will be recorded at the time of the procedure
Patient comfort score [1 day]
will be recorded at the time of the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Portsmouth Hospitals NHS Trust	Portsmouth	Hampshire	United Kingdom	PO6 3LY

Sponsors and Collaborators

Portsmouth Hospitals NHS Trust

Investigators

Principal Investigator: Pradeep Bhandari, MBBS, MD, MRCP, Portsmouth Hospitals NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Portsmouth Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT02529007

Other Study ID Numbers:

PHT/2013/71

First Posted:

Aug 19, 2015

Last Update Posted:

May 30, 2016

Last Verified:

Jul 1, 2015

Keywords provided by Portsmouth Hospitals NHS Trust

Colonoscopy

early cancer detection

cancer screening

Additional relevant MeSH terms:

Colonic Neoplasms

Polyps

Colonic Polyps

Study Results

No Results Posted as of May 30, 2016