Trial Outcomes & Findings for Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy (NCT NCT03160859)
NCT ID: NCT03160859
Last Updated: 2023-12-12
Results Overview
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Results posted on
2023-12-12
Participant Flow
Subjects will be selected from patients scheduled for colonoscopy as part of their routine care. Eligible subjects will be asked to sign the ICF. Control and study methods will be explained, and study subjects will undergo a questionnaire, physical examination, and unsedated colonoscopy with the standard (control) or study methods. Ineligible patients will be offered unsedated colonoscopy by standard method, outside the research study.
Participant milestones
| Measure |
Control Method
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
|
Study Method
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
143
|
|
Overall Study
COMPLETED
|
137
|
143
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
Baseline characteristics by cohort
| Measure |
Control Method
n=137 Participants
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
|
Study Method
n=143 Participants
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
137 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
137 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hourPain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
Outcome measures
| Measure |
Control Method
n=137 Participants
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
|
Study Method
n=143 Participants
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
|
|---|---|---|
|
Real Time Maximum Insertion Pain
|
2.6 score on a scale
Standard Deviation 2.4
|
2.9 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hourProportion of patients who report no pain during insertion of the colonoscope.
Outcome measures
| Measure |
Control Method
n=137 Participants
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
|
Study Method
n=143 Participants
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
|
|---|---|---|
|
Proportion of Patients With No Insertion Pain
|
38 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hourTime to cecum (clock display on monitor), faster insertion is a quality marker
Outcome measures
| Measure |
Control Method
n=137 Participants
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
|
Study Method
n=143 Participants
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
|
|---|---|---|
|
Insertion Time
|
18.8 Minutes
Standard Deviation 15.9
|
18.6 Minutes
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hourRight colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.
Outcome measures
| Measure |
Control Method
n=137 Participants
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
|
Study Method
n=143 Participants
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
|
|---|---|---|
|
Right Colon Adenoma Detection Rate (ADR)
|
40 Participants
|
27 Participants
|
Adverse Events
Control Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Method
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
Felix W. Leung, M.D, Staff Gastroenterologist
Veterans Administration Greater Los Angeles Healthcare System
Phone: 818-891-7711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place