Clinical trial NCT03361917: Standard Colonoscopy Versus Colonoscopy With Endocuff Vision
Official title: Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyp
Colorectal Adenoma
Colon Cancer
Keywords: Colonoscopy screening
Colonscopy procedure
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
timeFrame: During the withdrawal portion of the colonoscopy procedure
Secondary outcomes:
measure: Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
timeFrame: During the insertion portion of the colonoscopy procedure
measure: Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
timeFrame: During the colonoscopy procedure
measure: Detection Rates
timeFrame: During the colonoscopy procedure
measure: Polyps Per Colonoscopy
timeFrame: During the colonoscopy procedure
measure: Boston Bowel Preparation Score
timeFrame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13.
citation: Rex DK, Slaven JE, Garcia J, Lahr R, Searight M, Gross SA. Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jan;18(1):158-162.e1. doi: 10.1016/j.cgh.2019.01.015. Epub 2019 Jan 17.