Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy

Colorectal Cancer Clinical Trial

— COLD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763425
• Other study ID #: 200888
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: November 17, 2015
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2015
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• cold polypectomy
The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.
• conventional polypectomy
The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.

Locations

Country	Name	City	State
Japan	Showa Inan General hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete removal rate of colorectal polyps		two weeks after each polypectomy	No
Secondary	Complication rate		two weeks after each polypectomy	Yes