Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
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|ClinicalTrials.gov Identifier: NCT02387593|
Recruitment Status : Unknown
Verified September 2014 by Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was: Recruiting
First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.
The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.
The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.
There is insufficient evidence of the usefulness of endocuf
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Canceer||Device: ENDOCUFF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||April 2015|
Experimental: colonoscopy with endocuff
To the usual colonoscopy will place a endocuff at the tip of the colonoscope
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
No Intervention: standard colonoscopy without endocuff
Routine colonoscopy without endocuff
- Adenoma detection rate [ Time Frame: 30 minutes ]Percentage of adenomas detected during colonoscopy
- Measurement of the polyp detection rate [ Time Frame: 30 minutes ]Percentage of polyps detected during colonoscopy
- Cecal intubation rate [ Time Frame: 30 minutes ]Percentage of cecal intubation
- ileal intubation rate [ Time Frame: 10 minutes ]Percentage of ileal intubation
- Difficulty performing polypectomy [ Time Frame: 10 minutes ]When the endoscopist requiring special maneuvers to perform polypectomy
- Complications during colonoscopy [ Time Frame: One week ]When patients require special handling during or immediately subsequent colonoscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387593
|Contact: Rafael RB Barreto Zúñiga, MD||0155- 54870900 ext firstname.lastname@example.org|
|Contact: Rafael Rafael, MD||0155-54870900 ext email@example.com|
|México, Tlalpan, Mexico, 14000|
|Contact: Rafael Barreto, MD 54870900 ext 2150 firstname.lastname@example.org|
|Principal Investigator:||Rafael Rafael, MD||Department of Endoscopy|