An interventional study of CO2 and Water in Colon Mucous and Colonoscopy, sponsored by Evergreen General Hospital, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Evergreen General Hospital, Taiwan · Not applicable, Interventional, and Screening
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.
Evergreen General Hospital, Taiwan is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: CO2
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.
Other: Water
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.
Other: 50% 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.
Other: 25% saline
using CO2 insufflation to help insertion
using water instead of traditional gas to help insertion
using 50% saline solution instead of traditional gas to help insertion
using 25% saline solution instead of traditional gas to help insertion
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.
Time frame: 2 hours (data collected during colonoscopy procedure)
Adenoma Detection Rate
The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports.
Time frame: one week (data analyzed after the pathology results were available)
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
Time frame: 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.
Time frame: 2 hours (data collected during colonoscopy procedure)
Cecal Intubation Time
Total time from insertion into the anus to arrival in the cecum
Time frame: 2 hours (data collected during colonoscopy procedure)
Withdrawal Inspection Time
Total inspection time during withdrawal from the cecum to the anus
Time frame: 2 hours (data collected during colonoscopy procedure)
| Milestone | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Started | 73 | 75 | 76 | 77 |
| Completed | 70 | 75 | 76 | 75 |
| Not completed | 3 | 0 | 0 | 2 |
| Withdrew: Colorectal cancer obstruction | 2 | 0 | 0 | 0 |
| Withdrew: Failed cecal intubation | 1 | 0 | 0 | 1 |
| Withdrew: Poor bowel preparation | 0 | 0 | 0 | 1 |
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.
| score on a scale | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Left Colon Mucus Score | 0.2 ± 0.38 | 1.4 ± 0.84 | 0.5 ± 0.50 | 0.7 ± 0.63 |
The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports.
| Participants | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Adenoma Detection Rate | 35 | 31 | 41 | 35 |
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
| Participants | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Number of Participants With Cecal Intubation | 70 | 75 | 76 | 75 |
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.
| score on a scale | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Boston Bowel Preparation Scale Score | 7.0 ± 0.5 | 7.1 ± 0.7 | 7.8 ± 0.7 | 7.6 ± 0.7 |
Total time from insertion into the anus to arrival in the cecum
| minutes | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Cecal Intubation Time | 10.0 ± 6.0 | 18.0 ± 6.2 | 18.4 ± 7.1 | 18.6 ± 9.1 |
Total inspection time during withdrawal from the cecum to the anus
| minutes | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline |
|---|---|---|---|---|
| Withdrawal Inspection Time | 20.2 ± 6.4 | 17.1 ± 5.4 | 17.2 ± 5.3 | 16.6 ± 5.4 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CO2 Insufflation | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| WE With Water | 0/75 (0%) | 0/75 (0%) | 0/75 (0%) |
| WE With 50% Saline | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| WE With 25% Saline | 0/75 (0%) | 0/75 (0%) | 0/75 (0%) |
| Age, Continuous(years) | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline | Total |
|---|---|---|---|---|---|
| Mean | 51.2 ± 10.0 | 51.4 ± 10.7 | 53.0 ± 11.5 | 52.0 ± 10.9 | 51.9 ± 10.9 |
| Sex: Female, Male(Participants) | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline | Total |
|---|---|---|---|---|---|
| Female | 37 | 32 | 43 | 38 | 150 |
| Male | 33 | 43 | 33 | 37 | 146 |
| Race and Ethnicity Not Collected(Participants) | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | CO2 Insufflation | WE With Water | WE With 50% Saline | WE With 25% Saline | Total |
|---|---|---|---|---|---|
| Taiwan | 70 | 75 | 76 | 75 | 296 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Evergreen General Hospital, Taiwan