Full Text View
Tabular View
No Study Results Posted
Related Studies
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy (COLD)
This study is currently recruiting participants.
Verified by Showa Inan General Hospital, September 2008
First Received: September 29, 2008   Last Updated: October 2, 2008   History of Changes
Sponsor: Showa Inan General Hospital
Information provided by: Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00763425
  Purpose

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.


Condition Intervention
Colorectal Cancer
Procedure: cold polypectomy
Procedure: conventional polypectomy

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • Complete removal rate of colorectal polyps [ Time Frame: two weeks after each polypectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: two weeks after each polypectomy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Procedure: cold polypectomy
The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.
2: Active Comparator Procedure: conventional polypectomy
The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763425

Locations
Japan, Nagano
Showa Inan General hospital Recruiting
Komagane, Nagano, Japan, 399-4191
Contact: Akira Horiuchi, M.D.     +81265822121 ext 3012     horiuchi.akira@sihp.jp    
Principal Investigator: Akira Horiuchi, M.D.            
Sponsors and Collaborators
Showa Inan General Hospital
  More Information

No publications provided

Responsible Party: Showa Inan General Hospital ( Akira Horiuchi )
Study ID Numbers: 200888
Study First Received: September 29, 2008
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00763425     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa Inan General Hospital:
polypectomy
colonic polyp
colorectal polyp
colorectal cancer prevention

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009