None listed
Conditions
Brief summary
This study involves using a new imaging processor (TXI) while performing a colonoscopy looking for colon polyps (pre-cancerous growths). The aim is to assess whether TXI is able to detect more polyps than usual colonoscopic imaging. In order to determine if there is any significant difference, we will randomise patients either to a routine colonoscopy or to colonoscopy using TXI. We will then document the number of polyps found with each imaging type if they are confirmed as pre-cancerous when examined by a pathologist under the microscopy, then compare the two methods statistically.
Interventions
Brief name: Texture and Colour Enhancement Imaging (TXI) at Colonoscopy
This study will involve the use of TXI, a new form of imaging processing on the EVIS X1 Olympus endoscopy system.
Participants who have been referred for colonoscopy are randomized to receive a colonoscopy examination using either a WLE or TXI using the same processor.
In each study Participant the colonoscope will be inserted to the caecum, then based on randomization, colonic mucosa will be examined using either WLE or
Brief name: Texture and Colour Enhancement Imaging (TXI) at Colonoscopy This study will involve the use of TXI, a new form of imaging processing on the EVIS X1 Olympus endoscopy system. Participants who have been referred for colonoscopy are randomized to receive a colonoscopy examination using either a WLE or TXI using the same processor. In each study Participant the colonoscope will be inserted to the caecum, then based on randomization, colonic mucosa will be examined using either WLE or TXI on scope withdrawal. An endoscopy assistant will time the procedure starting from scope withdrawal using a stopwatch. The watch will be stopped at the time of polyp removal/biopsies. A minimum of 6 minutes withdrawal time is stipulated. Recorded parameters include number and location of adenomas, their size, morphology and pit pattern according to the Kudo’s and NICE classification. Switching from WLE to TXI and vice versa is permitted at the discretion of endoscopist after detection of an adenoma. Endoscopists may elect to remove these adenomas using WLE. Adenoma size is measured by a comparison to known diameter of open forceps and grouped into size categories. The decision to perform biopsies or hot/cold snare will be left up to the discretion of the endoscopist. Each polyp will be retrieved separately for pathologic examination. The procedures will all be performed by experienced gastroenterologists in a tertiary teaching hospital.
Sponsors
Edward Young
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients referred for colonoscopy
Exclusion criteria
Exclusion Criteria 1. Inability or refusal to give informed consent 2. Patients with coagulation disorders 3. Patients with significant comorbidity, which includes severe heart failure, chronic renal disease, severe chronic obstructive airways disease. 4. Patients who are pregnant 5. Personal history of inflammatory bowel disease 6. Family history of Familial Adenomatous Polyposis or familial non-polyposis syndrome
Outcome results
None listed