Colonoscopy, Polyp of Colon
Conditions
Keywords
colonoscopy, adenoma detection rate, caps
Brief summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients that require a routine or repeat colonoscopy. There will be three arms in this study: WE water control, water plus Cap-1, and water plus Cap-2. The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air inserted into the colon. The study method will use a new accessory, a cap that will fit onto the end of the colonoscope plus water during the procedure. This study will also confirm if using the cap method with water is a better way of detecting polyps in the colon and possibly cancer.
Detailed description
This will be a multi-site, multi-national, unblinded investigators, prospective Random Control Trial (RCT). Randomization (WE, WE Cap-1, WE Cap-2) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with three arms (WE, WE Cap-1, WE Cap-2) to see which one is better at detecting adenomas. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening or surveillance). Mode of sedation will include unsedated (China, US West Los Angeles VA), minimally sedated (Taiwan), on demand sedation (Italy, Czech Republic, US West Los Angeles VA), conscious sedation (US Sacramento VA and Palo Alto VA) or full sedation with propofol (Taiwan). Randomization (prepared by statistics consultant) will be carried out by the method of random permuted block design (based on computer generated random numbers) with variable block sizes of 3 and 6. Gender will be used as a stratification factor. Control Method: One arm of the study will include sedated/unsedated colonoscopy with water (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: The other two arms entail the addition of a simple commercially available accessory to the colonoscopy device: Cap -1 (Disposable Distal Attachment) or Cap-2, fitted to the colonoscope per manufacturer instruction. The two arms include sedated/unsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water.
Interventions
DEVICECAP-straight
This study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
DEVICECAP-daisy
This study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
OTHERwater
using water instead of traditional air insufflation to help insertion
Sponsors
University of California, Los Angeles
VA Greater Los Angeles Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female 50-75 yrs of age. 2. Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT). 3. Subjects willing to undergo routine screening and surveillance colonoscopy.
Exclusion criteria
1. Patients who decline to provide informed consent. 2. Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions. 3. Patients know to have prior history of severe diverticulitis/diverticulosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 2 years | The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation | 2 hours: Data collected during colonoscopy procedure | Visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum |
| Boston bowel preparation score | 2 hours: Data collected during colonoscopy procedure | Three segments (Right, transverse, left colon), each with 0 to 3 (poor to excellent); total scores = sum (10 point scale) |
| Cecal intubation time | 2 hours: Data collected during colonoscopy procedure | Total time from insertion into the anus to arrival in the cecum |
| Visual analogue scale (0=not satisfied, 10=very satisfied) | 2 hours: Data collected during colonoscopy procedure | Patient satisfaction |
| Willing to repeat | 2 hours: Data collected during colonoscopy procedure | Visual analogue scale (0=not willing, 10=willing) |
Countries
China, Italy, Taiwan, United States
Contacts
Primary ContactVivek Dixit, PhD
Backup ContactFelix W Leung, MD
Outcome results
None listed