Adenoma
Conditions
Keywords
Screening colonoscopy
Brief summary
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.
Detailed description
This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are: 1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap. 2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap. 3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy. 4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
Interventions
DEVICECap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
DEVICEConventional colonoscopy
Regular colonoscopy as per standard clinical guidelines
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
Exclusion criteria
1. Patients younger than 18 yrs old or older than 80 yrs. 2. Patients with a prior history of colonic surgeries 3. Patient with Crohns colitis or ulcerative colitis. 4. Patient with prior history of colon cancer 5. Patient with poor bowel preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap. | 1 year | 1\. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cap Assisted Colonoscopy Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.
Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate | 223 |
| Conventional Colonoscopy A conventional colonoscopy does not use a Cap in order to perform the procedure
Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines | 217 |
| Total | 440 |
Baseline characteristics
| Characteristic | Cap Assisted Colonoscopy | Conventional Colonoscopy | Total |
|---|---|---|---|
| Adenoma Detection Rate | 66 Participants | 69 Participants | 135 Participants |
| Advanced adenoma detection rate | 21 Participants | 10 Participants | 31 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 220 Participants | 212 Participants | 432 Participants |
| Age, Continuous | 59.48 years STANDARD_DEVIATION 7.28 | 60.08 years STANDARD_DEVIATION 7.26 | 60 years STANDARD_DEVIATION 7 |
| Polyp detection rate | 87 Participants | 92 Participants | 179 Participants |
| Sex: Female, Male Female | 146 Participants | 155 Participants | 301 Participants |
| Sex: Female, Male Male | 77 Participants | 62 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 0 / 214 |
| other Total, other adverse events | 0 / 211 | 0 / 214 |
| serious Total, serious adverse events | 1 / 211 | 0 / 214 |
Outcome results
Primary
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
1\. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cap Assisted Colonoscopy | ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap. | 66 Participants |
| Conventional Colonoscopy | ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap. | 69 Participants |