The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
This study is currently recruiting participants.
Verified December 2012 by Texas Tech University Health Sciences Center
Sponsor:
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01601431
First received: May 14, 2012
Last updated: December 11, 2012
Last verified: December 2012
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
Primary Outcome Measures:
- ADR differences in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Polyp detection rate in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Cecal intubation rate and time in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Complication rate in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cap Assisted Colonoscopy |
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 |
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:
- Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
- Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
Exclusion Criteria:
- Patients younger than 18 yrs old or older than 80 yrs.
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis.
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601431
Contacts
| Contact: Mohamed O Othman, MD | 915-545-6640 | mohamed.othman@ttuhsc.edu |
Locations
| United States, Texas | |
| Texas Tech University Health Sciences Center at El Paso | Recruiting |
| El Paso, Texas, United States, 79905 | |
| Contact: Mohamed O Othman, MD 915-545-6640 | |
| Principal Investigator: Mohamed O Othman, MD | |
| Sub-Investigator: Marc Zuckerman, MD | |
| Sub-Investigator: Richard Guerrero, MD | |
| Sub-Investigator: Brian Davis, MD | |
Sponsors and Collaborators
Texas Tech University Health Sciences Center
More Information
No publications provided
| Responsible Party: | Texas Tech University Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT01601431 History of Changes |
| Other Study ID Numbers: | E12050 |
| Study First Received: | May 14, 2012 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Tech University Health Sciences Center:
|
Screening colonoscopy |
Additional relevant MeSH terms:
|
Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 13, 2013