Clinical Trial: Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and Small Colorectal Polyps

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and Small Colorectal Polyps: a Randomized Controlled Trial

Brief Summary:

Background:The optimal technique for removal of diminutive or small colorectal polyps is debatable.

Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm).

Design：Prospective randomized controlled study. Setting：Three tertiary referral hospitals. Patients：we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a computer-generated random sequence. If a patient had one or more polyps, all eligible polyps were removed using the initially assigned polypectomy protocol. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.

Main Outcome Measurements:The primary study outcome was to compare the complete polyp resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval(Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site).


Detailed Summary:

1、study objective and Contents

Study objective:

Compare cold snare polypectomy with cold forceps polypectomy with respect to their efficacy and safety for endoscopic resection of small colorectal polyps: a randomized controlled trial.

Study content:

  1. Main Outcome Measurements: The primary study outcome was to compare the complete polyp resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval(Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site).
  2. Collect the pre-operation and post-operation data of patients who underwent a colonoscopy in the digestive disease center of Wulumuqi General Hospital of Lanzhou Militery Cammand from December 2015. to July 2014.Collect patients clinical data,Laboratory examination data, baseline data. 2、Key technical indicators and Solutions （1）key technique: After each polypectomy, additional EMR was performed at the polypectomy site, including an additional 1 to 2 mm clear margin, was resected by the snare,to evaluate for the presence of residual polyp tissue.

（2）the implementation of colorectal polypectomy: the polypectomy will be performed by experienced clinician, our Department of Gastroenterology and Hepatology has conducted nearly thousand colorectal polypectomy,and is a national leader in this technology. All the operation done by our team, all the members of our team has been trained to operate according to the operation standardization.All points mention
Sponsor: Wulumuqi General Hospital of Lanzhou Military Command

Current Primary Outcome: complete polyp resection rate [ Time Frame: one year ]

The primary study outcome was to compare the complete polyp resection rate between groups.Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site.


Original Primary Outcome: Same as current

Current Secondary Outcome: rate of postpolypectomy adverse events [ Time Frame: one year ]

Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval


Original Secondary Outcome: Same as current

Information By: Wulumuqi General Hospital of Lanzhou Military Command

Dates:
Date Received: March 17, 2016
Date Started: February 2016
Date Completion: December 2016
Last Updated: April 24, 2016
Last Verified: April 2016