Clinical Trial: Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Randomized Study Comparing Jumbo Cold Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps

Brief Summary: The purpose of this study is to evaluate and compare the incomplete resection rates for small colon polyps less than or equal to 6 mm in size using two conventional polypectomy tools, jumbo cold biopsy forceps and cold snare.

Detailed Summary:

The study is a prospective, randomized controlled study involving outpatients undergoing routine colonoscopy. The study is conducted at two academic medical centers, the Veterans Affairs (VA) San Diego Healthcare System and the University of California San Diego (UCSD) Thornton Hospital. Written informed consent is obtained from all participants prior to any study related procedures. Upon enrollment, each patient is randomized via a computer generated randomization scheme to a polypectomy device, either jumbo cold biopsy forceps or cold snare. The randomly allocated polypectomy device is used for polyp resection for polyps less than or equal to 6 mm in size.

All patients undergo standard bowel preparation with 4 liters of polyethylene glycol solution for routine colonoscopy. All colonoscopies are performed using standard colonoscopes (Olympus CF/PCF 160, CF/PCF 180, H-CF/H-PCF 180). Polypectomy tools used are: Olympus Biopsy Forceps, Boston Scientific RJ4 Biopsy Forceps, Boston Scientific Captiflex Extra Small Oval Flexible Snare, US Endoscopy Dsnare Dimunitive Polypectomy and Suction System, and the Boston Scientific Sensation Short Throw Oval Flexible Snare. For all polyps less than or equal to 6 mm in size, documentation of polyp size and anatomic location is conducted.

The jumbo capacity cold forceps polypectomy technique is performed via the following method: After inspection of the polyp, one or more biopsies are taken of the polyp followed by retrieval of the specimens directly from the biopsy forceps. Thereafter, the polypectomy site is vigorously irrigated and visually inspected for evidence of residual polypoid tissue. If residual polypoid tissue is suspected, additional biopsies are taken until the site is considered devoid of polypoid tissue. The total number of bites required for visual completion of polypecto
Sponsor: San Diego Veterans Healthcare System

Current Primary Outcome: Incomplete resection rate [ Time Frame: One week after colonoscopy date (when pathology results are available) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Rate of tissue retrieval [ Time Frame: 1 day (At time of colonoscopy) ]

  Documentation of whether resected polyp tissue is actually retrieved for placement into specimen jar.

  Rate of tissue retrieval = Number of effectively retrieved polyps for placement into specimen jar / Total number of resected polyps

• Rate of procedure-related complications [ Time Frame: 1 day (At time of colonoscopy) ]

  The two procedure related complications that were specifically assessed were post-polypectomy bleeding or perforation.

  Rate of procedure-related complications = Number of colonoscopies with complication of post-polypectomy bleeding or perforation / Total number of colonoscopies

Original Secondary Outcome: Same as current

Information By: San Diego Veterans Healthcare System

Dates:
Date Received: September 10, 2014
Date Started: April 2009
Date Completion:
Last Updated: September 11, 2014
Last Verified: September 2014