Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

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: Colorectal Canceer
• Intervention / Treatment: Device: ENDOCUFF

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

Study Locations

• Mexico
  • Tlalpan
    • México, Tlalpan, Mexico, 14000
      • Recruiting
      • Rafael Barreto
      • Contact: Rafael Barreto, MD; Phone Number: 2150 54870900; Email: barretozu@yahoo.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Percentage of adenomas detected during colonoscopy	30 minutes
Measurement of the polyp detection rate	Percentage of polyps detected during colonoscopy	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: Rafael Rafael, MD, Department of Endoscopy

Study record dates

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: Screening; Colonoscopy; Adenoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: END-1302-14/15-1