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Prospective Comparison of Cold Polypectomy and Conventional Polypectomy for Small Colorectal Polyps in Patients Taking Antithrombotic Agents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
ClinicalTrials.gov Identifier:
NCT01553565
First received: March 10, 2012
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose
  1. Background: The ideal method to remove small colorectal polyps in patients who are taking antithrombotic agents is unknown.
  2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete retrieval rate after the removal by colon snare transection without electrocautery for small polyps in patients who are taking antithrombotic agents.
  3. Design: A prospective, consecutive study.
  4. Setting: Municipal hospital outpatients.
  5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for colorectal polyps up to 10 mm in diameter in patients who continue to take antithrombotic agents. The primary outcome measure was bleeding within two weeks after polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal polyps based on the pathological examination.

Condition Intervention
Colorectal Polyps
 Procedure: Cold polypectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • Postpolypectomy bleeding [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Bleeding within two weeks after polypectomy


Secondary Outcome Measures:
  • Complete retrieval rate of colorectal polyps [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The complete retrieval rate of colorectal polyps based on the pathological examination.


Estimated Enrollment: 160
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional polypectomy
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed with electrocautery. Submucosal injection of some solution before the removal are not performed.
 Procedure: Cold polypectomy
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed. The technique is cold resection of the polyp without tenting and then suction of the transected polyp into a trap followed by submission to histopathological evaluation.
Other Name: Cold snare polypectomy
Experimental: Cold polypectomy Procedure: Cold polypectomy
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed. The technique is cold resection of the polyp without tenting and then suction of the transected polyp into a trap followed by submission to histopathological evaluation.
Other Name: Cold snare polypectomy

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with colorectal polyps up to 10 mm in diameter. The patients continue to take antithrombotic agents.

Exclusion Criteria:

  • patients are less than 20 years old,
  • pregnant,
  • American Society of Anesthesiologists class III and IV,
  • overweight (body weight > 100 kg), or
  • allergic to propofol used or its components (soybeans or eggs),
  • with previous colorectal surgical resection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553565

Locations
Japan
Showa Inan General Hospital
Komagane, Nagano, Japan, 399-4117
Sponsors and Collaborators
Showa Inan General Hospital
Investigators
Principal Investigator: Akira Horiuchi, MD Showa Inan General Hospital
  More Information

No publications provided

Responsible Party: Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT01553565     History of Changes
Other Study ID Numbers: cold vs.hot
Study First Received: March 10, 2012
Last Updated: March 15, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa Inan General Hospital:
10 mm in diameter
antithrombotic agents

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Fibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 19, 2013