Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

Phase 4

Completed

• Conditions: Polyp of Large Intestine
• Interventions: Procedure: removal of eligible polyps using double biopsy technique; Procedure: removal of eligible polyps using cold snare polypectomy technique

• Registration Number: NCT01646242
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients over the age of 20
• Informed consent

Exclusion Criteria

• Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
• Known existing bleeding tendency (thrombocytopenia or prolonged INR)
• Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
• ASA class III or more
• Pregnancy
• Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double biopsy polypectomy	removal of eligible polyps using double biopsy technique	-
Cold snare polypectomy	removal of eligible polyps using cold snare polypectomy technique	-

Primary Outcome Measures

Name	Time	Method
Complete histologic polyp eradication rate	2 weeks

Secondary Outcome Measures

Name	Time	Method
Time taken for polypectomy (complete visual eradication of each polyp)	2 weeks	time from polyp resection to tissue retrieval
Successful tissue retrieval rate of removed tissues	2 weeks
Rates of adverse events	4 weeks	Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).
Complete visual polyp eradication rate	2 weeks

Trial Locations

Locations (1)

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of