Trial Outcomes & Findings for Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used? (NCT NCT04769739)
NCT ID: NCT04769739
Last Updated: 2024-01-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
2 hours (data collected during colonoscopy procedure)
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
75
|
76
|
77
|
|
Overall Study
COMPLETED
|
70
|
75
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
Colorectal cancer obstruction
|
2
|
0
|
0
|
0
|
|
Overall Study
Failed cecal intubation
|
1
|
0
|
0
|
1
|
|
Overall Study
Poor bowel preparation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 10.0 • n=70 Participants
|
51.4 years
STANDARD_DEVIATION 10.7 • n=75 Participants
|
53.0 years
STANDARD_DEVIATION 11.5 • n=76 Participants
|
52.0 years
STANDARD_DEVIATION 10.9 • n=75 Participants
|
51.9 years
STANDARD_DEVIATION 10.9 • n=296 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=70 Participants
|
32 Participants
n=75 Participants
|
43 Participants
n=76 Participants
|
38 Participants
n=75 Participants
|
150 Participants
n=296 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=70 Participants
|
43 Participants
n=75 Participants
|
33 Participants
n=76 Participants
|
37 Participants
n=75 Participants
|
146 Participants
n=296 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
70 Participants
n=70 Participants
|
75 Participants
n=75 Participants
|
76 Participants
n=76 Participants
|
75 Participants
n=75 Participants
|
296 Participants
n=296 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
|---|---|---|---|---|
|
Left Colon Mucus Score
|
0.2 score on a scale
Standard Deviation 0.38
|
1.4 score on a scale
Standard Deviation 0.84
|
0.5 score on a scale
Standard Deviation 0.50
|
0.7 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: one week (data analyzed after the pathology results were available)The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports.
Outcome measures
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
|---|---|---|---|---|
|
Adenoma Detection Rate
|
35 Participants
|
31 Participants
|
41 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 2 hours (data collected during colonoscopy procedure)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
Outcome measures
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Cecal Intubation
|
70 Participants
|
75 Participants
|
76 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: 2 hours (data collected during colonoscopy procedure)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.
Outcome measures
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
|---|---|---|---|---|
|
Boston Bowel Preparation Scale Score
|
7.0 score on a scale
Standard Deviation 0.5
|
7.1 score on a scale
Standard Deviation 0.7
|
7.8 score on a scale
Standard Deviation 0.7
|
7.6 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 2 hours (data collected during colonoscopy procedure)Total time from insertion into the anus to arrival in the cecum
Outcome measures
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
|---|---|---|---|---|
|
Cecal Intubation Time
|
10.0 minutes
Standard Deviation 6.0
|
18.0 minutes
Standard Deviation 6.2
|
18.4 minutes
Standard Deviation 7.1
|
18.6 minutes
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: 2 hours (data collected during colonoscopy procedure)Total inspection time during withdrawal from the cecum to the anus
Outcome measures
| Measure |
CO2 Insufflation
n=70 Participants
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
|
WE With Water
n=75 Participants
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
|
WE With 50% Saline
n=76 Participants
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
|
WE With 25% Saline
n=75 Participants
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
|
|---|---|---|---|---|
|
Withdrawal Inspection Time
|
20.2 minutes
Standard Deviation 6.4
|
17.1 minutes
Standard Deviation 5.4
|
17.2 minutes
Standard Deviation 5.3
|
16.6 minutes
Standard Deviation 5.4
|
Adverse Events
CO2 Insufflation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WE With Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WE With 50% Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WE With 25% Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place