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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 insufflation | Active Comparator | Colonoscopy will be performed in the traditional fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. |
|
| WE with water | Active Comparator | Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion. |
|
| WE with 50% saline | Experimental | Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. |
|
| WE with 25% saline | Experimental | Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 | Other | using CO2 insufflation to help insertion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Left Colon Mucus Score | The amount of residual mucus in the left colon (descending colon, sigmoid colon, rectum) is scaled by a mucus score (5-point scale): score 0: no visible mucus; score 1: minimal amounts of clear mucus in thin streaks or strands; score 2: mild opaque mucus in thin strands; score 3: moderate opaque mucus in thicker clumps covering one side of surface; score 4: more opaque mucus in thicker clumps covering more views of lumen. | 2 hours (data collected during colonoscopy procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate | The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports. | one week (data analyzed after the pathology results were available) |
| Number of Participants With Cecal Intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiliang Cheng, MD | Evergreen General Hospital, Taoyuan, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evergreen General Hospital | Taoyuan | 320 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32458999 | Background | 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. | |
| 30367879 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CO2 Insufflation | Colonoscopy will be performed in the traditional fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. CO2: using CO2 insufflation to help insertion |
| FG001 | WE With Water | Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion. Water: using water instead of traditional gas to help insertion |
| FG002 | WE With 50% Saline | Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 50% saline: using 50% saline solution instead of traditional gas to help insertion |
| FG003 | WE With 25% Saline | Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 25% saline: using 25% saline solution instead of traditional gas to help insertion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CO2 Insufflation | Colonoscopy will be performed in the traditional fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. CO2: using CO2 insufflation to help insertion |
| BG001 | WE With Water |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Colon Mucus Score | The amount of residual mucus in the left colon (descending colon, sigmoid colon, rectum) is scaled by a mucus score (5-point scale): score 0: no visible mucus; score 1: minimal amounts of clear mucus in thin streaks or strands; score 2: mild opaque mucus in thin strands; score 3: moderate opaque mucus in thicker clumps covering one side of surface; score 4: more opaque mucus in thicker clumps covering more views of lumen. | Posted | Mean | Standard Deviation | score on a scale | 2 hours (data collected during colonoscopy procedure) |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CO2 Insufflation | Colonoscopy will be performed in the traditional fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. CO2: using CO2 insufflation to help insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chi-Liang Cheng | Evergreen General Hospital | 0919768058 | chiliang.cheng@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 | Apr 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014867 | Water |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Water |
| Other |
using water instead of traditional gas to help insertion |
|
| 50% saline | Other | using 50% saline solution instead of traditional gas to help insertion |
|
| 25% saline | Other | using 25% saline solution instead of traditional gas to help insertion |
|
Number of participants who had a colonoscopy images confirming visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum |
| 2 hours (data collected during colonoscopy procedure) |
| Boston Bowel Preparation Scale Score | Three iindividual segments (right colon, transverse colon, left colon), each with score of 0 to 3 (poor to excellent) will be evlauated separately using the Boston Bowel Preparation Scale. A tota Boston Bowel Preparation Scale score, sum of three-segmental score (range 0-9), will be reported. | 2 hours (data collected during colonoscopy procedure) |
| Cecal Intubation Time | Total time from insertion into the anus to arrival in the cecum | 2 hours (data collected during colonoscopy procedure) |
| Withdrawal Inspection Time | Total inspection time during withdrawal from the cecum to the anus | 2 hours (data collected during colonoscopy procedure) |
| 20619405 | Background | 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. |
| 37141104 | Derived | Cheng CL, Kuo YL, Liu NJ, Lien JM, Su IC, Tang CP, Hsieh YH, Leung FW. Randomized Trial Comparing Left Colon Mucus Production Using Water vs Saline During Water Exchange Colonoscopy. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00594. doi: 10.14309/ctg.0000000000000594. |
| Failed cecal intubation |
|
| Poor bowel preparation |
|
Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion. Water: using water instead of traditional gas to help insertion |
| BG002 | WE With 50% Saline | Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 50% saline: using 50% saline solution instead of traditional gas to help insertion |
| BG003 | WE With 25% Saline | Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 25% saline: using 25% saline solution instead of traditional gas to help insertion |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| WE With Water |
Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion. Water: using water instead of traditional gas to help insertion |
| OG002 | WE With 50% Saline | Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 50% saline: using 50% saline solution instead of traditional gas to help insertion |
| OG003 | WE With 25% Saline | Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 25% saline: using 25% saline solution instead of traditional gas to help insertion |
|
|
| Secondary | Adenoma Detection Rate | The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports. | Posted | Count of Participants | Participants | one week (data analyzed after the pathology results were available) |
|
|
|
| Secondary | Number of Participants With Cecal Intubation | Number of participants who had a colonoscopy images confirming visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum | Posted | Count of Participants | Participants | 2 hours (data collected during colonoscopy procedure) |
|
|
|
| Secondary | Boston Bowel Preparation Scale Score | Three iindividual segments (right colon, transverse colon, left colon), each with score of 0 to 3 (poor to excellent) will be evlauated separately using the Boston Bowel Preparation Scale. A tota Boston Bowel Preparation Scale score, sum of three-segmental score (range 0-9), will be reported. | Posted | Mean | Standard Deviation | score on a scale | 2 hours (data collected during colonoscopy procedure) |
|
|
|
| Secondary | Cecal Intubation Time | Total time from insertion into the anus to arrival in the cecum | Posted | Mean | Standard Deviation | minutes | 2 hours (data collected during colonoscopy procedure) |
|
|
|
| Secondary | Withdrawal Inspection Time | Total inspection time during withdrawal from the cecum to the anus | Posted | Mean | Standard Deviation | minutes | 2 hours (data collected during colonoscopy procedure) |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | WE With Water | Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion. Water: using water instead of traditional gas to help insertion | 0 | 75 | 0 | 75 | 0 | 75 |
| EG002 | WE With 50% Saline | Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 50% saline: using 50% saline solution instead of traditional gas to help insertion | 0 | 76 | 0 | 76 | 0 | 76 |
| EG003 | WE With 25% Saline | Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. 25% saline: using 25% saline solution instead of traditional gas to help insertion | 0 | 75 | 0 | 75 | 0 | 75 |
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| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
| Male |
|