Colorectal Canceer
Conditions
Keywords
Adenoma, Colonoscopy, Screening
Brief summary
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
Detailed description
All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.
Interventions
DEVICEENDOCUFF
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult patients, * Aged 18, * Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies
Exclusion criteria
* Boston colonic preparation \<5 points * Suspected Lynch syndrome or familial adenomatous polyposis (FAP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 30 minutes | Percentage of adenomas detected during colonoscopy |
| Measurement of the polyp detection rate | 30 minutes | Percentage of polyps detected during colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation rate | 30 minutes | Percentage of cecal intubation |
| ileal intubation rate | 10 minutes | Percentage of ileal intubation |
| Difficulty performing polypectomy | 10 minutes | When the endoscopist requiring special maneuvers to perform polypectomy |
| Complications during colonoscopy | One week | When patients require special handling during or immediately subsequent colonoscopy |
Countries
Mexico
Contacts
Primary ContactRafael RB Barreto Zúñiga, MD
Backup ContactRafael Rafael, MD
Outcome results
None listed