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

Primary Purpose

Colonic Polyps, Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endo-cuff
Standard colonoscopy
Sponsored by
Portsmouth Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colonic Polyps focused on measuring Colonoscopy, early cancer detection, cancer screening

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Portsmouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Endocuff

Arm Description

These patients have standard colonoscopy performed

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

Outcomes

Primary Outcome Measures

Number of polyps detected per patient

Secondary Outcome Measures

Cancer detection rate
Polyp detection rate
Adenomas per patient
Adenoma detection rate
Caecal intubation rate
will be recorded at the time of the procedure
Total procedure time - from scope insertion to removal
will be recorded at the time of the procedure
Time taken to reach caecum
will be recorded at the time of the procedure
Time taken to withdraw scope (from caecum to removal of scope)
will be recorded at the time of the procedure
Patient comfort score
will be recorded at the time of the procedure

Full Information

First Posted
July 17, 2015
Last Updated
May 27, 2016
Sponsor
Portsmouth Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02529007
Brief Title
Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
Acronym
E-CAP
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portsmouth Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Colonic Neoplasms
Keywords
Colonoscopy, early cancer detection, cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
These patients have standard colonoscopy performed
Arm Title
Endocuff
Arm Type
Experimental
Arm Description
These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope
Intervention Type
Device
Intervention Name(s)
Endo-cuff
Intervention Description
Colonoscopy performed with endo-cuff attached to the colonoscope
Intervention Type
Other
Intervention Name(s)
Standard colonoscopy
Intervention Description
Standard colonoscopy without end-cuff
Primary Outcome Measure Information:
Title
Number of polyps detected per patient
Time Frame
1 month (when pathology report available)
Secondary Outcome Measure Information:
Title
Cancer detection rate
Time Frame
1 month (when pathology report available)
Title
Polyp detection rate
Time Frame
1 month (when pathology report available)
Title
Adenomas per patient
Time Frame
1 month (when pathology report available)
Title
Adenoma detection rate
Time Frame
1 month (when pathology report available)
Title
Caecal intubation rate
Description
will be recorded at the time of the procedure
Time Frame
1 day
Title
Total procedure time - from scope insertion to removal
Description
will be recorded at the time of the procedure
Time Frame
1 day
Title
Time taken to reach caecum
Description
will be recorded at the time of the procedure
Time Frame
1 day
Title
Time taken to withdraw scope (from caecum to removal of scope)
Description
will be recorded at the time of the procedure
Time Frame
1 day
Title
Patient comfort score
Description
will be recorded at the time of the procedure
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Bhandari, MBBS, MD, MRCP
Organizational Affiliation
Portsmouth Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28614895
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.
Results Reference
derived

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

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