Colon Cancer, Colorectal Adenoma, Colorectal Polyp
Conditions
Keywords
Colonoscopy
Brief summary
The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
Detailed description
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.
Interventions
DEVICEEndoRings device
Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.
Sponsors
US Endoscopy
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Screening or Surveillance Colonoscopy * Able to provide written informed consent
Exclusion criteria
* Known narrow colon or colon stenosis * Personal history of Colorectal cancer * History of inflammatory bowel disease * Familial adenomatous polyposis syndrome (FAP) * Hyperplastic polyposis syndrome * Referral for incomplete colonoscopy or polyp clearance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rates | During colonoscopy procedure | Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings. |
| Number of Adenomas Per Colonoscopy | During colonoscopy procedure | Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Detections | During colonoscopy procedure | Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy. |
| Cecal Intubation Rate | During colonoscopy procedure | Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy. |
| Polyp Detection Rate | During colonoscopy procedure | Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings. |
| Patient Comfort Score | After colonoscopy was completed while patient was in recovery area of endoscopy unit | Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome). |
| Problems Encountered With Equipment | During colonoscopy procedure | Occurrences of slippage of EndoRings or of device being removed on insertion. |
| Time Comparison for Each Method | During colonoscopy procedure | Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal). |
| Number of Detections Per Colonoscopy | During colonoscopy procedure | Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy. |
Countries
United States
Participant flow
Recruitment details
592 patients were enrolled in the study, but 17 were excluded before randomization for not meeting inclusion criteria. 569 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| EndoRings Colonoscopy Colonoscopy with EndoRings device attached to the distal end of the scope.
EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure. | 284 |
| Control Arm (Standard Colonoscopy) Standard colonoscopy with no device attachment. | 278 |
| Total | 562 |
Baseline characteristics
| Characteristic | Control Arm (Standard Colonoscopy) | Total | EndoRings Colonoscopy |
|---|---|---|---|
| Age, Continuous | 61.0 Years STANDARD_DEVIATION 7.9 | 61.5 Years STANDARD_DEVIATION 9.1 | 61.9 Years STANDARD_DEVIATION 8.1 |
| Indication for Colonoscopy Patients who had a screening colonoscopy | 162 Participants | 305 Participants | 143 Participants |
| Indication for Colonoscopy Patients who had a surveillance colonoscopy | 116 Participants | 257 Participants | 141 Participants |
| Race/Ethnicity, Customized Other | 56 Participants | 107 Participants | 51 Participants |
| Race/Ethnicity, Customized White | 222 Participants | 455 Participants | 233 Participants |
| Region of Enrollment United States | 278 participants | 562 participants | 284 participants |
| Sex: Female, Male Female | 142 Participants | 273 Participants | 131 Participants |
| Sex: Female, Male Male | 136 Participants | 289 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 284 | 0 / 278 |
| other Total, other adverse events | 0 / 284 | 0 / 278 |
| serious Total, serious adverse events | 0 / 284 | 0 / 278 |
Outcome results
Primary
Adenoma Detection Rates
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRings Colonoscopy | Adenoma Detection Rates | 143 Participants |
| Control Arm (Standard Colonoscopy) | Adenoma Detection Rates | 124 Participants |
Primary
Number of Adenomas Per Colonoscopy
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoRings Colonoscopy | Number of Adenomas Per Colonoscopy | 1.46 adenomas per colonoscopy | Standard Deviation 2.69 |
| Control Arm (Standard Colonoscopy) | Number of Adenomas Per Colonoscopy | 1.06 adenomas per colonoscopy | Standard Deviation 1.83 |
Secondary
Cecal Intubation Rate
Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRings Colonoscopy | Cecal Intubation Rate | 281 Participants |
| Control Arm (Standard Colonoscopy) | Cecal Intubation Rate | 277 Participants |
Secondary
Number of Detections Per Colonoscopy
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoRings Colonoscopy | Number of Detections Per Colonoscopy | 2.29 polyps per colonoscopy | Standard Deviation 3.09 |
| Control Arm (Standard Colonoscopy) | Number of Detections Per Colonoscopy | 1.82 polyps per colonoscopy | Standard Deviation 2.19 |
Secondary
Patient Comfort Score
Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
Time frame: After colonoscopy was completed while patient was in recovery area of endoscopy unit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoRings Colonoscopy | Patient Comfort Score | 0.47 units on a scale | Standard Deviation 1.1 |
| Control Arm (Standard Colonoscopy) | Patient Comfort Score | 0.36 units on a scale | Standard Deviation 0.9 |
Secondary
Polyp Detection Rate
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRings Colonoscopy | Polyp Detection Rate | 199 Participants |
| Control Arm (Standard Colonoscopy) | Polyp Detection Rate | 188 Participants |
Secondary
Problems Encountered With Equipment
Occurrences of slippage of EndoRings or of device being removed on insertion.
Time frame: During colonoscopy procedure
Population: This outcome measure is not applicable for patients randomized to the standard arm because there is no device attached in the standard arm of the study. For this reason, 0 patients are reported for the standard arm for this specific outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EndoRings Colonoscopy | Problems Encountered With Equipment | Procedures where device was removed | 25 Participants |
| EndoRings Colonoscopy | Problems Encountered With Equipment | Procedures with slippage of device | 17 Participants |
Secondary
Time Comparison for Each Method
Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
Time frame: During colonoscopy procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoRings Colonoscopy | Time Comparison for Each Method | Insertion Time | 6.3 Minutes | Standard Deviation 4.4 |
| EndoRings Colonoscopy | Time Comparison for Each Method | Total Withdrawal Time | 11.8 Minutes | Standard Deviation 6.1 |
| EndoRings Colonoscopy | Time Comparison for Each Method | Total Procedure Time | 19.4 Minutes | Standard Deviation 8.2 |
| Control Arm (Standard Colonoscopy) | Time Comparison for Each Method | Insertion Time | 5.5 Minutes | Standard Deviation 3.4 |
| Control Arm (Standard Colonoscopy) | Time Comparison for Each Method | Total Withdrawal Time | 12.8 Minutes | Standard Deviation 5.9 |
| Control Arm (Standard Colonoscopy) | Time Comparison for Each Method | Total Procedure Time | 19.5 Minutes | Standard Deviation 7.9 |
Secondary
Total Number of Detections
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EndoRings Colonoscopy | Total Number of Detections | Adenomas | 650 Detections |
| EndoRings Colonoscopy | Total Number of Detections | Polyps | 415 Detections |
| Control Arm (Standard Colonoscopy) | Total Number of Detections | Polyps | 295 Detections |
| Control Arm (Standard Colonoscopy) | Total Number of Detections | Adenomas | 506 Detections |