None listed
Conditions
Brief summary
Patients with ulcerative colitis or Crohn's colitis have a slightly higher risk of bowel cancer after having the disease for a number of years. Colonoscopy is recommended to find polyps which can be flat and sometimes difficult to detect. This study aims to test the safety and efficacy of a new device named the Endocuff-vision, for surveillance for cancer and dysplasia in inflammatory bowel disease. Who is it for? You may be eligible to join this study if you aged 18 years or above and have ulcerative colitis or Crohn’s colitis involving more than one third of the colon in clinical remission, and are planned for routine colonoscopy for dysplasia surveillance. Study details All participants in this study will proceed with regular colonoscopy with the addition of the use of Endocuff-vision equipment during the procedure. This is a soft, rubber-like cap that fits to the end of the regular colonoscopy equipment, with a row of finger-like projections that extend when the colonoscope is pulled out. The aim of this device is to assist in anchoring the bowel wall and flattening mucosal folds to allow better vision of the bowel. The duration of the colonoscopy will be longer by about 10 - 15 minutes, as we will do the colonoscopy first without the Endocuff-vision device, then with the Endocuff-vision device, or vice versa. All test results will be analysed to determine whether the Endocuff-vision device is objectively better at detecting polyps. A member of the research team will also contact study participants at 21 days after the colonoscopy to ascertain if there have been any complications.
Interventions
This is a back-to-back crossover tandem colonoscopy study comparing the Endocuff device and standard care (high definition white light endoscopy with chromoendoscopy) compared with standard care alone for dysplasia surveillance in patients with inflammatory bowel disease. The Endocuff device is a small cap that attaches to the end of a standard colonoscope. Small, soft, finger-like projections extend from this cap on withdrawal of the colonoscope with the aim of flattening mucosal folds, anchori
This is a back-to-back crossover tandem colonoscopy study comparing the Endocuff device and standard care (high definition white light endoscopy with chromoendoscopy) compared with standard care alone for dysplasia surveillance in patients with inflammatory bowel disease. The Endocuff device is a small cap that attaches to the end of a standard colonoscope. Small, soft, finger-like projections extend from this cap on withdrawal of the colonoscope with the aim of flattening mucosal folds, anchoring the colonoscope and thus improving rate of dysplasia detection. The colonoscopies will be performed by endoscopists with training and experience in performing dye-spray chromoendoscopy, interventional endoscopy and who have had previous experience using the Endocuff device. All patients will receive two passes with the colonoscopy (one standard, and one with Endocuff) during the same anaesthetic, on the same day. Approximate length of each procedure will be about 15-20 minutes with a few minutes between crossover. This will occur at an endoscopy suite within Eastern Health. Follow-up will be via phone call at days 1, 7 and 21 post-procedure.
Sponsors
Eastern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
All patients with ulcerative colitis or Crohn’s colitis involving more than one third of the colon in clinical remission, planned for routine colonoscopy for dysplasia surveillance.
Exclusion criteria
• Patients with absolute or relative contraindications to colonoscopy • Patients with established or suspicion of large bowel obstruction or pseudo-obstruction • Patients with known colon cancer or polyposis syndromes • Patients with known colonic strictures • Patients with a known severe diverticular segment (that is likely to impede colonoscope passage); • Patients with clinical suspicion of active ulcerative colitis • Patients lacking capacity to give informed consent • Patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure • Patients who are attending for a therapeutic procedure or assessment of a known lesion • Pregnancy.
Outcome results
None listed