Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy (COLD)

The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.

Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: cold polypectomy; Procedure: conventional polypectomy

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Nagano
    • Komagane, Nagano, Japan, 399-4191
      • Showa Inan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Men or women between 20 and 100 years of age

Exclusion Criteria:

• Exclusion criteria include age less than 20 years old
• Pregnant, American Society of Anesthesiologists class III and IV
• Overweight (body weight > 100 kg)
• Allergic to the drugs used or its components (soybeans or eggs)
• Poor bowel preparation or post-colorectal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Procedure: cold polypectomy; The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.; Other Names: cold snare polypectomy
Active Comparator: 2	Procedure: conventional polypectomy; The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.; Other Names: polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete removal rate of colorectal polyps	two weeks after each polypectomy

Secondary Outcome Measures

Outcome Measure	Time Frame
Complication rate	two weeks after each polypectomy

Collaborators and Investigators

• Sponsor: Showa Inan General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: polypectomy; colonic polyp; colorectal polyp; colorectal cancer prevention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 200888