Colonoscopy
Conditions
Keywords
Colonoscopy, colon cancer screening
Brief summary
The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.
Interventions
DEVICEConventional Pediatric Colonoscope
DEVICEShort-Turn Radius Colonoscope
Sponsors
Pentax Medical
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide Informed Consent * Age \> 40 * Surveillance Colonoscopy (History of Adenomas)
Exclusion criteria
* Poor or Fair Bowel Prep * Difficult First Insertion * Familial Polyposis * Inflammatory Bowel Disease * Pregnancy * Active GI Bleeding * Prior colonic or rectal resection * Conserved Sattus * Colonoscopy less than 3 years ago * Screening Colonoscopy * Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With At Least One Adenoma | 1 hour | Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Polyp Detection Rate | 1 hour | Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope. |
| Mean Number of Adenomas Identified Per Patient With Polyps | 1 hour | Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Size of Polyps Detected | 1 hour | Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares). |
| Size of Adenomas Detected | 1 hour | — |
Participant flow
Pre-assignment details
89 subjects were excluded (poor bowel preparation \[n = 45\], prior colonic resection \[n = 3\], difficult first insertion \[n=45\], not over 40 \[n = 1\], no history of adenomatous colorectal polyps \[n = 1\], device related reasons \[n = 1\])
Participants by arm
| Arm | Count |
|---|---|
| Short-Turn Radius Colonoscope Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.
Short-Turn Radius Colonoscope | 101 |
| Conventional Pediatric Colonoscope Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.
Conventional Pediatric Colonoscope | 93 |
| Total | 194 |
Baseline characteristics
| Characteristic | Conventional Pediatric Colonoscope | Total | Short-Turn Radius Colonoscope |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 8.38 | 65.9 years STANDARD_DEVIATION 8.2 | 66.2 years STANDARD_DEVIATION 8.13 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 93 participants | 194 participants | 101 participants |
| Sex: Female, Male Female | 59 Participants | 118 Participants | 59 Participants |
| Sex: Female, Male Male | 34 Participants | 76 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 93 |
| other Total, other adverse events | 0 / 101 | 0 / 93 |
| serious Total, serious adverse events | 0 / 101 | 0 / 93 |
Outcome results
Primary
Percentage of Patients With At Least One Adenoma
Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short-Turn Radius Colonoscope | Percentage of Patients With At Least One Adenoma | 63 Participants |
| Conventional Pediatric Colonoscope | Percentage of Patients With At Least One Adenoma | 68 Participants |
Secondary
Mean Number of Adenomas Identified Per Patient With Polyps
Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short-Turn Radius Colonoscope | Mean Number of Adenomas Identified Per Patient With Polyps | 2.48 Number of Adenomas Per Patient | Standard Deviation 2.05 |
| Conventional Pediatric Colonoscope | Mean Number of Adenomas Identified Per Patient With Polyps | 2.50 Number of Adenomas Per Patient | Standard Deviation 1.56 |
Secondary
Overall Polyp Detection Rate
Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short-Turn Radius Colonoscope | Overall Polyp Detection Rate | 72 Participants |
| Conventional Pediatric Colonoscope | Overall Polyp Detection Rate | 78 Participants |
Other Pre-specified
Size of Adenomas Detected
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short-Turn Radius Colonoscope | Size of Adenomas Detected | 5.15 mm | Standard Deviation 3.04 |
| Conventional Pediatric Colonoscope | Size of Adenomas Detected | 4.69 mm | Standard Deviation 2.4 |
Other Pre-specified
Size of Polyps Detected
Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short-Turn Radius Colonoscope | Size of Polyps Detected | 4.89 mm | Standard Deviation 2.92 |
| Conventional Pediatric Colonoscope | Size of Polyps Detected | 4.50 mm | Standard Deviation 2.3 |