Endocuff Adenoma Detection Rate Pilot Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Adenoma Colorectal Cancer |
Device: Endocuff attachment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps |
- Proportion of patients with adenomas and cancers detected [ Time Frame: immediate ] [ Designated as safety issue: No ]
- Caecal intubation time [ Time Frame: Immediate ] [ Designated as safety issue: No ]
- Caecal intubation rate [ Time Frame: immediate ] [ Designated as safety issue: No ]
- Polyp detection rate [ Time Frame: immediate ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Endocuff assisted colonoscopy
Endocuff attachment
|
Device: Endocuff attachment
Endocuff
Other Name: ARC endocuff
|
|
Placebo Comparator: Control standard colonoscopy
Standard colonoscopy
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Contraindication to undergo standard colonoscopy.
- Severe active colitis.
- Known colonic stricture
Contacts and Locations| United Kingdom | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, United Kingdom, CB2OQQ | |
| Contact: Ewen Cameron, MBBS 01223 348718 ewen.cameron@addenbrookes.nhs.uk | |
| Principal Investigator: Rob Mead, MBBS | |
| Principal Investigator: | Ewen Cameron, MBBS | Cambridge University Hospitals NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Rob Mead, Dr. R.J.Mead, Cambridge University Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01761097 History of Changes |
| Other Study ID Numbers: | AO92673 |
| Study First Received: | January 3, 2013 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
|
Adenoma, polyp, colonoscopy. |
Additional relevant MeSH terms:
|
Adenoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013