Endocuff Adenoma Detection Rate Pilot Study

NCT01761097 | Unknown

• 1 other identifier: AO92673
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope. The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.

Conditions

Colorectal Adenoma; Colorectal Cancer

Keywords

Adenoma, polyp, colonoscopy.

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with adenomas and cancers detected

  immediate

Secondary Outcomes (1)

• Caecal intubation time

  Immediate

Other Outcomes (2)

• Caecal intubation rate

  immediate

• Polyp detection rate

  immediate

Study Arms (2)

Endocuff assisted colonoscopy

ACTIVE COMPARATOR

Endocuff attachment

Device: Endocuff attachment

Control standard colonoscopy

PLACEBO COMPARATOR

Standard colonoscopy

Interventions

Endocuff attachment DEVICE

Endocuff

Also known as: ARC endocuff

Endocuff assisted colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
• Ability to understand the nature and requirements of the study and to provide written informed consent.

You may not qualify if:

• Contraindication to undergo standard colonoscopy.
• Severe active colitis.
• Known colonic stricture

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2OQQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma; Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ewen Cameron, MBBS

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. R.J.Mead

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 4, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

GB (1)