Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

N/ACompletedNCT03361917

Indiana University200 enrolled

Overview

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

Colorectal Polyp Colorectal Adenoma Colon Cancer

Interventions

Endocuff VisionDEVICE

Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject referred for a screening or surveillance colonoscopy * Subject is aged 40 years or older * Subject has the ability to provide informed consent Exclusion Criteria: * Prior history of colon cancer * History of inflammatory bowel disease * Prior surgical resection of any part of the colon * Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure * History of polyposis syndrome or HNPCC * Family history of colon cancer in a first-degree relative \< 60 years or two first degree relatives with colorectal cancer * Inability to provide informed consent

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)

Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

Time frame: During the withdrawal portion of the colonoscopy procedure

Secondary Outcomes

Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)

Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.

Time frame: During the insertion portion of the colonoscopy procedure

Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)

Total procedure time is the time from the initial insertion through the complete withdrawal of the scope

Time frame: During the colonoscopy procedure

Detection Rates

The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.

Time frame: During the colonoscopy procedure

Polyps Per Colonoscopy

Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.

Time frame: During the colonoscopy procedure

Boston Bowel Preparation Score

Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist.

Data from ClinicalTrials.gov

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