Clinical trial NCT04769739: Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used?
Official title: Comparing Left Colon Mucus Production by Water Versus Saline Infusion During Water Exchange Colonoscopy: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Mucous
Colonoscopy
Keywords: Colonoscopy
Colon Mucus
Water Exchange
Saline
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 301
Sex: ALL
Minimum age (years): 20
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 the left colon mucus production between carbon dioxide (CO2) insufflation and water exchange (WE) colonoscopy in patients that require a routine or repeat colonoscopy. There will be four arms in this study: CO2 insufflation (control group 1), WE with water infusion (control group 2), WE with 50% saline infusion (study group 1), and WE with 25% saline infusion (study group 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 WE control group will use sterile water filling during colonoscope insertion. The study method will use saline filling during colonoscopy insertion. This study will confirm if using the saline infusion is a better method in reducing mucus production when WE colonoscopy is used.

Detailed description: This will be a single-site (Evergreen General Hospital, Taoyuan, Taiwan), blinded investigators, prospective randomized controlled trial (RCT). Felix W. Leung (from Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills, CA) will be involved in the study design, data analysis, and report preparation, but not in patient enrollment. Randomization (CO2, WE with water, WE with 50% saline, WE with 25% saline) 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 insertion methods with four arms (CO2 insufflation, WE with water, WE with 50% saline, WE with 25% saline) to see which solution used in WE is better in reducing mucus production.

Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Randomization will be stratified by investigators and indication of colonoscopy (screening, surveillance, or positive fecal immunochemical test). All participating patients will receive conscious sedation during the colonoscopic examination. 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 of 3 and 6.

Control method: One arm of the study will include colonoscopy with water infusion during insertion as the control method. Residual air in the colon will be removed and sterile 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. Another arm of the study will include colonoscopy with CO2 insufflation during insertion as an additional control method.

Study method: Two arms of the study will include colonoscopy with saline infusion of different strength, i.e., 50% saline and 25% saline, during insertion. Residual air in the colon will be removed and saline solution will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual fecal debris, predominantly during insertion.

Eligibility criteria: Inclusion Criteria:

* Male and female 20-75 years of age
* Positive screening for Fecal Immunochemical Test (FIT)
* Subjects willing to undergo routine screening and surveillance colonoscopy

Exclusion Criteria:

* Patients who decline to provide informed consent
* Patients known to have colonic obstruction, active inflammatory bowel disease, or active GI bleeding requiring interventions
* Patients known to have prior history of colonic resection
* Patients with genetic colorectal syndromes
* Patients who are scheduled for therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
* Patients with American Society of Anesthesiology classification of physical status grade 3 or higher

Primary outcomes:
measure: Left Colon Mucus Score
timeFrame: 2 hours (data collected during colonoscopy procedure)
Secondary outcomes:
measure: Adenoma Detection Rate
timeFrame: one week (data analyzed after the pathology results were available)
measure: Number of Participants With Cecal Intubation
timeFrame: 2 hours (data collected during colonoscopy procedure)
measure: Boston Bowel Preparation Scale Score
timeFrame: 2 hours (data collected during colonoscopy procedure)
measure: Cecal Intubation Time
timeFrame: 2 hours (data collected during colonoscopy procedure)
measure: Withdrawal Inspection Time
timeFrame: 2 hours (data collected during colonoscopy procedure)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Evergreen General Hospital
Study officials:
affiliation: Evergreen General Hospital, Taoyuan, Taiwan
name: Chiliang Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Rahyel A, McWhinney CD, Parsa N, Lahr RE, Vemulapalli KC, Rex DK. Room temperature water infusion during colonoscopy insertion induces rectosigmoid colon mucus production. Endoscopy. 2020 Dec;52(12):1118-1121. doi: 10.1055/a-1182-5211. Epub 2020 Jun 15.
citation: Anderson JC, Kahi CJ, Sullivan A, MacPhail M, Garcia J, Rex DK. Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach. Gastrointest Endosc. 2019 Mar;89(3):591-598. doi: 10.1016/j.gie.2018.09.046. Epub 2018 Oct 24.
citation: Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.