Colon MucousNCT04769739
Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used?
A study testing CO2, Water and 50% saline in people with Colon Mucous and Colonoscopy, run by Evergreen General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Mucous, Colonoscopy
- What is being tested?
- CO2, Water and 50% saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female 20-75 years of age
- Positive screening for Fecal Immunochemical Test (FIT)
- Subjects willing to undergo routine screening and surveillance colonoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Left Colon Mucus Production by Water Versus Saline Infusion During Water Exchange Colonoscopy: a Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Colon Mucous, Colonoscopy
- Being tested
- CO2, Water, 50% saline, 25% saline
- Keywords
- Colonoscopy, Colon Mucus, Water Exchange, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Other
using CO2 insufflation to help insertion
WaterOther
using water instead of traditional gas to help insertion
50% salineOther
using 50% saline solution instead of traditional gas to help insertion
25% salineOther
using 25% saline solution instead of traditional gas to help insertion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CO2 |
| 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. Receives: Other: Water |
| 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. Receives: Other: 50% saline |
| 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. Receives: Other: 25% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours (data collected during colonoscopy procedure)
Secondary outcomes (5)
Adenoma Detection Rate
The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports.
Measured: 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
Measured: 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.
Measured: 2 hours (data collected during colonoscopy procedure)
Cecal Intubation Time
Total time from insertion into the anus to arrival in the cecum
Measured: 2 hours (data collected during colonoscopy procedure)
Withdrawal Inspection Time
Total inspection time during withdrawal from the cecum to the anus
Measured: 2 hours (data collected during colonoscopy procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start4 Aug 2021
- Primary completion23 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon MucousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiliang Cheng, MD, Principal investigator, Evergreen General Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769739
- Sponsor's protocol ID
- EGH-2021-2
- Status last verified
- Apr 2023
- First submitted
- 23 Feb 2021
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32458999Anderson 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.
PubMed 30367879Leung 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.
PubMed 20619405Cheng 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.
PubMed 37141104
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Left Colon Mucus Production by Water Versus Saline Infusion During Water Exchange Colonoscopy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04769739
- Acronym / sponsor ID
- EGH-2021-2
- Conditions
- Colon Mucous, Colonoscopy
- Keywords
- Colonoscopy, Colon Mucus, Water Exchange, Saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CO2 insufflation | Active comparator | Other: CO2Colonoscopy 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 | Other: WaterResidual 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 | Other: 50% salineResidual 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 | Other: 25% salineResidual 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female 20-75 years of age
- Positive screening for Fecal Immunochemical Test (FIT)
- Subjects willing to undergo routine screening and surveillance colonoscopy
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2using CO2 insufflation to help insertion | Other | CO2 insufflation |
| Waterusing water instead of traditional gas to help insertion | Other | WE with water |
| 50% salineusing 50% saline solution instead of traditional gas to help insertion | Other | WE with 50% saline |
| 25% salineusing 25% saline solution instead of traditional gas to help insertion | Other | WE with 25% saline |
Primary outcome
Left Colon Mucus Score
Time frame: 2 hours (data collected during colonoscopy procedure)
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.
5 secondary outcomes
Adenoma Detection Rate
Time frame: one week (data analyzed after the pathology results were available)
Number of Participants With Cecal Intubation
Time frame: 2 hours (data collected during colonoscopy procedure)
Boston Bowel Preparation Scale Score
Time frame: 2 hours (data collected during colonoscopy procedure)
Cecal Intubation Time
Time frame: 2 hours (data collected during colonoscopy procedure)
Withdrawal Inspection Time
Time frame: 2 hours (data collected during colonoscopy procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32458999El 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.
- Background: PubMed 30367879Anderson 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.
- Background: PubMed 20619405Leung 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.
- Derived from this study: PubMed 37141104Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiliang Cheng, MD principal investigator
Evergreen General Hospital, Taoyuan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2, Water and 50% saline in people with Colon Mucous and Colonoscopy, run by Evergreen General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Colon Mucus Score (time frame: 2 hours (data collected during colonoscopy procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769739, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.