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The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

This study has been terminated.
(Study was inactivated by the IRB since PI left institution.)
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier:
NCT01601431
First received: May 14, 2012
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.

Condition Intervention
Adenoma Device: Cap Assisted Colonoscopy Device: Conventional colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center, El Paso:

Primary Outcome Measures:
  • ADR differences in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ]
    1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.


Secondary Outcome Measures:
  • Polyp detection rate in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ]
    2. Compare overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.

  • Cecal intubation rate and time in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ]
    1. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.

  • Complication rate in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ]
    2. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.


Enrollment: 440
Actual Study Start Date: March 29, 2012
Study Completion Date: February 2, 2015
Primary Completion Date: February 2, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cap Assisted Colonoscopy
Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.
Device: Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Active Comparator: Conventional colonoscopy
A conventional colonoscopy does not use a Cap in order to perform the procedure
Device: Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Device: Conventional colonoscopy
Regular colonoscopy as per standard clinical guidelines

Detailed Description:

This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

  1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
  2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
  3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
  4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria:

  1. Patients younger than 18 yrs old or older than 80 yrs.
  2. Patients with a prior history of colonic surgeries
  3. Patient with Crohns colitis or ulcerative colitis.
  4. Patient with prior history of colon cancer
  5. Patient with poor bowel preparation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601431

Locations
United States, Texas
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
Principal Investigator: Mohamed O Othman, MD Texas Tech University Health Sciences Center
  More Information

Responsible Party: Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT01601431     History of Changes
Other Study ID Numbers: E12050
Study First Received: May 14, 2012
Last Updated: April 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Texas Tech University Health Sciences Center, El Paso:
Screening colonoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2017