Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Unknown

Conditions: Colorectal Canceer

Treatments: Device: ENDOCUFF

Study type: Interventional

Funder types: Other

Identifiers

NCT02387593

END-1302-14/15-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups

colonoscopy with endocuff

Experimental group

Description:

To the usual colonoscopy will place a endocuff at the tip of the colonoscope

Treatment:

Device: ENDOCUFF

standard colonoscopy without endocuff

No Intervention group

Description:

Routine colonoscopy without endocuff