Clinical trial NCT03566615: Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
Official title: Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Polyp of Colon
Keywords: colonoscopy
adenoma detection rate
caps
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
First posted: 2018-06-25
Enrollment: 1630
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 2 years
Secondary outcomes:
measure: Cecal intubation
timeFrame: 2 hours: Data collected during colonoscopy procedure
measure: Boston bowel preparation score
timeFrame: 2 hours: Data collected during colonoscopy procedure
measure: Cecal intubation time
timeFrame: 2 hours: Data collected during colonoscopy procedure
measure: Visual analogue scale (0=not satisfied, 10=very satisfied)
timeFrame: 2 hours: Data collected during colonoscopy procedure
measure: Willing to repeat
timeFrame: 2 hours: Data collected during colonoscopy procedure
Other outcomes:
Locations:
city: Mather
country: United States
facility: Sacramento VAMC, VA Northern California Healthcare System
state: California
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Healthcare System
state: California
city: Xian
country: China
facility: Xijing Hospital of Digestive Diseases
city: Iglesias
country: Italy
facility: St. Barbara Hospital
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi General Hospital
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Taipei
country: Taiwan
facility: Evergreen General Hospital
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Felix W Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: