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

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ClinicalTrials.gov Identifier: NCT02529007
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date May 30, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
Number of polyps detected per patient [ Time Frame: 1 month (when pathology report available) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • Cancer detection rate [ Time Frame: 1 month (when pathology report available) ]
  • Polyp detection rate [ Time Frame: 1 month (when pathology report available) ]
  • Adenomas per patient [ Time Frame: 1 month (when pathology report available) ]
  • Adenoma detection rate [ Time Frame: 1 month (when pathology report available) ]
  • Caecal intubation rate [ Time Frame: 1 day ]
    will be recorded at the time of the procedure
  • Total procedure time - from scope insertion to removal [ Time Frame: 1 day ]
    will be recorded at the time of the procedure
  • Time taken to reach caecum [ Time Frame: 1 day ]
    will be recorded at the time of the procedure
  • Time taken to withdraw scope (from caecum to removal of scope) [ Time Frame: 1 day ]
    will be recorded at the time of the procedure
  • Patient comfort score [ Time Frame: 1 day ]
    will be recorded at the time of the procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
Official Title  ICMJE Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE
  • Colonic Polyps
  • Colonic Neoplasms
Intervention  ICMJE
  • Device: Endo-cuff
    Colonoscopy performed with endo-cuff attached to the colonoscope
  • Other: Standard colonoscopy
    Standard colonoscopy without end-cuff
Study Arms  ICMJE
  • Active Comparator: Standard
    These patients have standard colonoscopy performed
    Intervention: Other: Standard colonoscopy
  • Experimental: Endocuff
    These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope
    Intervention: Device: Endo-cuff
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2015)
534
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02529007
Other Study ID Numbers  ICMJE PHT/2013/71
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Portsmouth Hospitals NHS Trust
Study Sponsor  ICMJE Portsmouth Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pradeep Bhandari, MBBS, MD, MRCP Portsmouth Hospitals NHS Trust
PRS Account Portsmouth Hospitals NHS Trust
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP