Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

March 12, 2015 updated by: Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Tlalpan
      • México, Tlalpan, Mexico, 14000
        • Recruiting
        • Rafael Barreto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: colonoscopy with endocuff
To the usual colonoscopy will place a endocuff at the tip of the colonoscope
Device: ENDOCUFF
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
No Intervention: standard colonoscopy without endocuff
Routine colonoscopy without endocuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 30 minutes
Percentage of adenomas detected during colonoscopy
30 minutes
Measurement of the polyp detection rate
Time Frame: 30 minutes
Percentage of polyps detected during colonoscopy
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cecal intubation rate
Time Frame: 30 minutes
Percentage of cecal intubation
30 minutes
ileal intubation rate
Time Frame: 10 minutes
Percentage of ileal intubation
10 minutes
Difficulty performing polypectomy
Time Frame: 10 minutes
When the endoscopist requiring special maneuvers to perform polypectomy
10 minutes
Complications during colonoscopy
Time Frame: One week
When patients require special handling during or immediately subsequent colonoscopy
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Rafael Rafael, MD, Department of Endoscopy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • END-1302-14/15-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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