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Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Primary Purpose

Colorectal Canceer

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
ENDOCUFF
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Canceer focused on measuring Adenoma, Colonoscopy, Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Rafael BarretoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

colonoscopy with endocuff

standard colonoscopy without endocuff

Arm Description

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

Routine colonoscopy without endocuff

Outcomes

Primary Outcome Measures

Adenoma detection rate
Percentage of adenomas detected during colonoscopy
Measurement of the polyp detection rate
Percentage of polyps detected during colonoscopy

Secondary Outcome Measures

Cecal intubation rate
Percentage of cecal intubation
ileal intubation rate
Percentage of ileal intubation
Difficulty performing polypectomy
When the endoscopist requiring special maneuvers to perform polypectomy
Complications during colonoscopy
When patients require special handling during or immediately subsequent colonoscopy

Full Information

First Posted
March 9, 2015
Last Updated
March 12, 2015
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02387593
Brief Title
Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
Official Title
Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Canceer
Keywords
Adenoma, Colonoscopy, Screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
colonoscopy with endocuff
Arm Type
Experimental
Arm Description
To the usual colonoscopy will place a endocuff at the tip of the colonoscope
Arm Title
standard colonoscopy without endocuff
Arm Type
No Intervention
Arm Description
Routine colonoscopy without endocuff
Intervention Type
Device
Intervention Name(s)
ENDOCUFF
Intervention Description
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
Percentage of adenomas detected during colonoscopy
Time Frame
30 minutes
Title
Measurement of the polyp detection rate
Description
Percentage of polyps detected during colonoscopy
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Cecal intubation rate
Description
Percentage of cecal intubation
Time Frame
30 minutes
Title
ileal intubation rate
Description
Percentage of ileal intubation
Time Frame
10 minutes
Title
Difficulty performing polypectomy
Description
When the endoscopist requiring special maneuvers to perform polypectomy
Time Frame
10 minutes
Title
Complications during colonoscopy
Description
When patients require special handling during or immediately subsequent colonoscopy
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael RB Barreto Zúñiga, MD
Phone
0155- 54870900
Ext
2150
Email
barretozu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Rafael, MD
Phone
0155-54870900
Ext
2150
Email
barretozu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Rafael, MD
Organizational Affiliation
Department of Endoscopy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rafael Barreto
City
México
State/Province
Tlalpan
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Barreto, MD
Phone
54870900
Ext
2150
Email
barretozu@yahoo.com

12. IPD Sharing Statement

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Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

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