Colorectal Neoplasms
Conditions
Brief summary
The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.
Interventions
DEVICEDevice Assisted Colonoscopy
This will be similar to the standard colonoscopy except the endocuff device will be used.
DEVICEStandard Colonoscopy
No endocuff device will be used on the study participants undergoing standard colonoscopy.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients undergoing first screening colonoscopy 2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies. 3. Ability to provide informed consent.
Exclusion criteria
1. Previous surgical resection of any part of the colon 2. history of colon cancer 3. history of inflammatory bowel disease 4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps 5. Poor general condition 6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer 7. Inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma detection rate (ADR) as determined by Colonoscopy | intraoperative |
| Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy | intraoperative |
Secondary
| Measure | Time frame |
|---|---|
| Cecal Intubation Rate (CIR) | intraoperative |
Countries
United States
Outcome results
None listed