Trial Outcomes & Findings for Water Immersion and Polyp Detection: A Randomized Controlled Trial (NCT NCT03231917)
NCT ID: NCT03231917
Last Updated: 2019-07-12
Results Overview
Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
Through procedure, an average of 1 hr
Results posted on
2019-07-12
Participant Flow
Participant milestones
| Measure |
Water Infusion First
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
|
CO2 Insufflation First
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Water Infusion First
n=60 Participants
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
|
CO2 Insufflation First
n=61 Participants
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.5 • n=60 Participants
|
63.4 years
STANDARD_DEVIATION 8.4 • n=61 Participants
|
63.4 years
STANDARD_DEVIATION 7.8 • n=121 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=60 Participants
|
12 Participants
n=61 Participants
|
28 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=60 Participants
|
49 Participants
n=61 Participants
|
93 Participants
n=121 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
60 participants
n=60 Participants
|
61 participants
n=61 Participants
|
121 participants
n=121 Participants
|
|
Monitored anesthesia care (MAC)
|
35 Participants
n=60 Participants
|
35 Participants
n=61 Participants
|
70 Participants
n=121 Participants
|
|
Colonoscopy ordered for screening purposes?
|
17 Participants
n=60 Participants
|
21 Participants
n=61 Participants
|
38 Participants
n=121 Participants
|
PRIMARY outcome
Timeframe: Through procedure, an average of 1 hrPopulation: Adenoma miss rate
Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations
Outcome measures
| Measure |
Water Infusion First
n=146 adenomas
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
|
CO2 Insufflation First
n=159 adenomas
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
|
|---|---|---|
|
Adenoma Miss Rate
|
52 adenomas missed by first exam
|
37 adenomas missed by first exam
|
SECONDARY outcome
Timeframe: 1 hour or the duration of the procedurePatient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination
Outcome measures
| Measure |
Water Infusion First
n=60 Participants
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
|
CO2 Insufflation First
n=61 Participants
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
|
|---|---|---|
|
Patient-level Miss Rate
|
27 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 1 hour or the duration of the procedurePopulation: Adenomas \< 6 mm
Adenoma-level miss rates will be calculated as the number of additional adenomas \< 6 mm detected during the second examination divided by the total number of adenomas\< 6 mm detected during both examinations.
Outcome measures
| Measure |
Water Infusion First
n=109 Adenomas < 6 mm
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
|
CO2 Insufflation First
n=128 Adenomas < 6 mm
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
|
|---|---|---|
|
Adenoma < 6mm Detection Rate
|
45 Adenomas < 6 mm
|
36 Adenomas < 6 mm
|
Adverse Events
Water Infusion First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CO2 Insufflation First
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