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Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps


N/A
21 Years
85 Years
Open (Enrolling)
Both
Adenoma, Colon Polyps, Colon Cancer

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Trial Information

Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps


The investigators hypothesize that adenoma detection rate will be higher using cap assisted
colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe
and cecal intubation rate will be similar compared to standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and
cap assisted colonoscopy.

Specific Aim 2 - To compare the number of adenomas detected per subject by standard
colonoscopy and cap assisted colonoscopy.

Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and
complications of standard colonoscopy and cap assisted colonoscopy.


Inclusion Criteria:



- Referral for screening and/or surveillance colonoscopy and the ability to provide
informed consent.

Exclusion Criteria:

- prior surgical resection of any portion of colon,

- prior history of colon cancer,

- history of inflammatory bowel disease,

- use of anti-platelet agents or anticoagulants that precludes removal of polyps during
the procedure,

- poor general condition or any other reason to avoid prolonged procedure time

- inability to give informed consent,

- inadequate bowel preparation.

- history of polyposis syndrome or HNPCC,

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

The primary outcome is the prevalence of adenomas in the two groups.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Amit Rastogi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Veterans Affairs Medical Center, Kansas City, MO

Authority:

United States: Institutional Review Board

Study ID:

AR0006

NCT ID:

NCT01211132

Start Date:

September 2009

Completion Date:

November 2010

Related Keywords:

  • Adenoma
  • Colon Polyps
  • Colon Cancer
  • Colon polyps
  • Adenoma detection
  • Cap
  • Standard
  • Colon Cancer
  • Adenoma
  • Colonic Neoplasms
  • Colonic Polyps
  • Polyps

Name

Location

Veterans Affairs Medical CenterKansas City, Missouri  64128