Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Not Applicable

• Conditions: Colorectal Canceer
• Interventions: Device: ENDOCUFF

• Registration Number: NCT02387593
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-12
• Last Update Submitted: 2015-03-12
• Study First Posted: 2015-03-13
• Last Update Posted: 2015-03-13
• Primary Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colonoscopy with endocuff	ENDOCUFF	To the usual colonoscopy will place a endocuff at the tip of the colonoscope

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Cecal intubation rate	30 minutes	Percentage of cecal intubation

Trial Locations

Locations (1)

Rafael Barreto; 🇲🇽 México, Tlalpan, Mexico