Colon Cancer, Colorectal Adenoma, Colorectal Polyp
Conditions
Keywords
Colonoscopy screening, Colonscopy procedure
Brief summary
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
Detailed description
For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.
Interventions
DEVICEEndocuff Vision
Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject referred for a screening or surveillance colonoscopy * Subject is aged 40 years or older * Subject has the ability to provide informed consent
Exclusion criteria
* Prior history of colon cancer * History of inflammatory bowel disease * Prior surgical resection of any part of the colon * Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure * History of polyposis syndrome or HNPCC * Family history of colon cancer in a first-degree relative \< 60 years or two first degree relatives with colorectal cancer * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) | During the withdrawal portion of the colonoscopy procedure | Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) | During the insertion portion of the colonoscopy procedure | Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached. |
| Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) | During the colonoscopy procedure | Total procedure time is the time from the initial insertion through the complete withdrawal of the scope |
| Detection Rates | During the colonoscopy procedure | The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision. |
| Polyps Per Colonoscopy | During the colonoscopy procedure | Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision. |
| Boston Bowel Preparation Score | During the withdrawal portion of the colonoscopy procedure after cleaning of the colon | Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endocuff Vision Colonoscopy with Endocuff Vision attached to distal end of scope
Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure. | 101 |
| Control Arm (Standard Colonscopy) Standard colonoscopy with no device attachments | 99 |
| Total | 200 |
Baseline characteristics
| Characteristic | Total | Endocuff Vision | Control Arm (Standard Colonscopy) |
|---|---|---|---|
| Age, Continuous | 62.2 Years STANDARD_DEVIATION 9.4 | 62.7 Years STANDARD_DEVIATION 8.9 | 61.7 Years STANDARD_DEVIATION 9.9 |
| Gastroenterology fellows assisting in insertion | 32 Participants | 17 Participants | 15 Participants |
| Procedure Indication Screening | 97 Participants | 45 Participants | 52 Participants |
| Procedure Indication Surveillance | 103 Participants | 56 Participants | 47 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 14 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 179 Participants | 87 Participants | 92 Participants |
| Region of Enrollment United States | 200 participants | 101 participants | 99 participants |
| Sex: Female, Male Female | 101 Participants | 44 Participants | 57 Participants |
| Sex: Female, Male Male | 99 Participants | 57 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 101 |
| other Total, other adverse events | 0 / 99 | 0 / 101 |
| serious Total, serious adverse events | 0 / 99 | 0 / 101 |
Outcome results
Primary
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
Time frame: During the withdrawal portion of the colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endocuff Vision | Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) | 6.49 Minutes | Standard Error 0.1 |
| Control Arm (Standard Colonscopy) | Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) | 8.42 Minutes | Standard Error 0.12 |
Secondary
Boston Bowel Preparation Score
Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist.
Time frame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endocuff Vision | Boston Bowel Preparation Score | 9 Scores on a scale |
| Control Arm (Standard Colonscopy) | Boston Bowel Preparation Score | 9 Scores on a scale |
Secondary
Detection Rates
The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
Time frame: During the colonoscopy procedure
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Endocuff Vision | Detection Rates | Adenomas | 61.4 Percentage of Participants |
| Endocuff Vision | Detection Rates | Sessile serrated polyps | 19.8 Percentage of Participants |
| Control Arm (Standard Colonscopy) | Detection Rates | Adenomas | 52.5 Percentage of Participants |
| Control Arm (Standard Colonscopy) | Detection Rates | Sessile serrated polyps | 11.1 Percentage of Participants |
Secondary
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
Time frame: During the insertion portion of the colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endocuff Vision | Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) | 4.05 Minutes | Standard Error 0.16 |
| Control Arm (Standard Colonscopy) | Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) | 4.42 Minutes | Standard Error 0.19 |
Secondary
Polyps Per Colonoscopy
Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
Time frame: During the colonoscopy procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Endocuff Vision | Polyps Per Colonoscopy | Adenomas | 1.43 Polyps per colonoscopy | Standard Error 1.79 |
| Endocuff Vision | Polyps Per Colonoscopy | Sessile serrated polyps | 0.27 Polyps per colonoscopy | Standard Error 0.63 |
| Control Arm (Standard Colonscopy) | Polyps Per Colonoscopy | Adenomas | 1.07 Polyps per colonoscopy | Standard Error 1.62 |
| Control Arm (Standard Colonscopy) | Polyps Per Colonoscopy | Sessile serrated polyps | 0.21 Polyps per colonoscopy | Standard Error 0.7 |
Secondary
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
Time frame: During the colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endocuff Vision | Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) | 21.01 Minutes | Standard Deviation 6.8 |
| Control Arm (Standard Colonscopy) | Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) | 21.24 Minutes | Standard Deviation 7.8 |