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Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02665741
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE January 28, 2016
Results First Submitted Date  ICMJE April 15, 2019
Results First Posted Date  ICMJE June 18, 2020
Last Update Posted Date June 18, 2020
Study Start Date  ICMJE January 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
Adenoma Detection Rate [ Time Frame: Completion of procedure ]
The investigators will compare adenoma detection rate at completion of study across the 3 arms
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
Adenoma Detection Rate [ Time Frame: 1 year ]
We will compare adenoma detection rate at completion of study across the 4 arms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • Proximal Adenoma Detection Rate [ Time Frame: Completion of procedure ]
    The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms
  • Cecal Intubation Rate [ Time Frame: Completion of procedure ]
    The investigators will compare cecal intubation rate at completion of study across the 3 arms
  • Withdrawal Time [ Time Frame: Completion of procedure ]
    The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
  • Proximal Adenoma Detection Rate [ Time Frame: 1 year ]
    We will compare proximal adenoma detection rate at completion of study across the 4 arms
  • Polyp detection rate [ Time Frame: 1 year ]
    We will compare polyp detection rate at completion of study across the 4 arms
  • Cecal Intubation Rate [ Time Frame: 1 year ]
    We will compare cecal intubation rate at completion of study across the 4 arms
  • Withdrawal Time [ Time Frame: 1 year ]
    We will compare colonoscopy withdrawal time rate at completion of study across the 4 arms
  • Major complications (perforation, bleeding requiring transfusion) [ Time Frame: 1 year ]
    We will compare major complications at completion of study across the 4 arms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Official Title  ICMJE Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Brief Summary The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.
Detailed Description

Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc.

Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a "split bowel preparation", which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube.

The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic folds. The use of Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well as adenoma detection rates 3.

The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and extends a short distance past the tip of the colonoscope. It aids in the manipulation of folds and in maintaining a suitable distance from the mucosa, with the goal of improving visualization. Although some studies comparing cap fitted colonoscopy to standard (non- attachment) colonoscopies have shown improved adenoma detection 4, others have shown no significant benefit 5.

Although, these devices have been compared with conventional colonoscopies (i.e without any distal attachment), to the investigator's knowledge, there are currently no studies that have compared these two distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects on detection of right sided adenomas. Also, here at UCDavis, these devices are being used specifically in diagnostic colonoscopies for removal of large polyps and the choice of which specific device is used depends on level of comfort of the advanced endoscopist. The endoscopists participating in the investigators' study do not currently use these devices as part of their routine colonoscopies, thus it is important to provide head to head comparison of these devices to help guide management practice.

Therefore, the investigators' goal is to compare the Endocuff overtube assisted, transparent cap fitted, and non-cap fitted (standard) colonoscopy in patients presenting to UC Davis Medical Center for screening colonoscopies.

In addition, 2 of the 3 investigators will employ the water exchange method during for all arms of the trial, while the other investigator will employ the conventional air method of colonoscopy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Colon Cancer Screening
  • Colon Polyps
  • Colon Adenomas
  • Water Exchange Colonoscopy
Intervention  ICMJE
  • Device: Olympus transparent cap
    distal colonoscope attachment
  • Device: Medivators Endocuff
    distal colonoscope attachment
  • Device: Control
    No distal colonoscope attachments
Study Arms  ICMJE
  • Control
    Standard colonoscopy - no distal colonoscope attachment will be used in this arm
    Intervention: Device: Control
  • Experimental: Olympus transparent cap
    The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
    Intervention: Device: Olympus transparent cap
  • Experimental: Medivators Endocuff
    The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
    Intervention: Device: Medivators Endocuff
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
126
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2016)
168
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 50 years old
  • Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites

Exclusion Criteria:

  • Age less than 50 years
  • Prior history of colon cancer
  • Patients with inflammatory bowel disease
  • Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).
  • Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon
  • Patients with family history of colon cancer in 1st degree relative below the age of 60
  • Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer
  • Patients unable to consent
  • Pregnant patients
  • Incarcerated patients
  • Non-English speakers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02665741
Other Study ID Numbers  ICMJE 797109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP