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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
Sponsor:
Information provided by (Responsible Party):
Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
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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


Condition or disease Intervention/treatment Phase
Colorectal Canceer Device: ENDOCUFF Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 30 minutes ]
    Percentage of adenomas detected during colonoscopy

  2. Measurement of the polyp detection rate [ Time Frame: 30 minutes ]
    Percentage of polyps detected during colonoscopy


Secondary Outcome Measures :
  1. Cecal intubation rate [ Time Frame: 30 minutes ]
    Percentage of cecal intubation

  2. ileal intubation rate [ Time Frame: 10 minutes ]
    Percentage of ileal intubation

  3. Difficulty performing polypectomy [ Time Frame: 10 minutes ]
    When the endoscopist requiring special maneuvers to perform polypectomy

  4. Complications during colonoscopy [ Time Frame: One week ]
    When patients require special handling during or immediately subsequent colonoscopy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Rafael RB Barreto Zúñiga, MD 0155- 54870900 ext 2150 barretozu@yahoo.com
Contact: Rafael Rafael, MD 0155-54870900 ext 2150 barretozu@yahoo.com

Locations
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Mexico
Rafael Barreto Recruiting
México, Tlalpan, Mexico, 14000
Contact: Rafael Barreto, MD    54870900 ext 2150    barretozu@yahoo.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Rafael Rafael, MD Department of Endoscopy
More Information
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Responsible Party: Dr. Rafael Barreto Zúñiga, Attached to the Department of Endoscopy Medical Institute, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02387593     History of Changes
Other Study ID Numbers: END-1302-14/15-1
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: September 2014
Keywords provided by Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Adenoma
Colonoscopy
Screening
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms