Colon Polyps Clinical Trial
Official title:
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
NCT number | NCT02665741 |
Other study ID # | 797109 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | February 2017 |
Verified date | June 2020 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.
Status | Completed |
Enrollment | 126 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - At least 50 years old - Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites Exclusion Criteria: - Age less than 50 years - Prior history of colon cancer - Patients with inflammatory bowel disease - Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema). - Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon - Patients with family history of colon cancer in 1st degree relative below the age of 60 - Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer - Patients unable to consent - Pregnant patients - Incarcerated patients - Non-English speakers |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30. — View Citation
Harada Y, Hirasawa D, Fujita N, Noda Y, Kobayashi G, Ishida K, Yonechi M, Ito K, Suzuki T, Sugawara T, Horaguchi J, Takasawa O, Obana T, Oohira T, Onochi K, Kanno Y, Kuroha M, Iwai W. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):637-44. doi: 10.1016/j.gie.2008.08.029. — View Citation
Pioche M, Matsumoto M, Takamaru H, Sakamoto T, Nakajima T, Matsuda T, Abe S, Kakugawa Y, Otake Y, Saito Y. Endocuff-assisted colonoscopy increases polyp detection rate: a simulated randomized study involving an anatomic colorectal model and 32 international endoscopists. Surg Endosc. 2016 Jan;30(1):288-95. doi: 10.1007/s00464-015-4208-8. Epub 2015 Apr 11. — View Citation
Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma Detection Rate | The investigators will compare adenoma detection rate at completion of study across the 3 arms | Completion of procedure | |
Secondary | Proximal Adenoma Detection Rate | The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms | Completion of procedure | |
Secondary | Cecal Intubation Rate | The investigators will compare cecal intubation rate at completion of study across the 3 arms | Completion of procedure | |
Secondary | Withdrawal Time | The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms | Completion of procedure |
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