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

Primary Purpose

Colorectal Polyps

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Cold polypectomy
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Polyps focused on measuring 10 mm in diameter, antithrombotic agents

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Showa Inan General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional polypectomy

Cold polypectomy

Arm Description

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.

Outcomes

Primary Outcome Measures

Postpolypectomy bleeding
Bleeding within two weeks after polypectomy

Secondary Outcome Measures

Complete retrieval rate of colorectal polyps
The complete retrieval rate of colorectal polyps based on the pathological examination.

Full Information

First Posted
March 10, 2012
Last Updated
August 13, 2014
Sponsor
Showa Inan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01553565
Brief Title
Prospective Comparison of Cold Polypectomy and Conventional Polypectomy for Small Colorectal Polyps in Patients Taking Antithrombotic Agents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: The ideal method to remove small colorectal polyps in patients who are taking antithrombotic agents is unknown. 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. Design: A prospective, consecutive study. Setting: Municipal hospital outpatients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyps
Keywords
10 mm in diameter, antithrombotic agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional polypectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cold polypectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cold polypectomy
Other Intervention Name(s)
Cold snare polypectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postpolypectomy bleeding
Description
Bleeding within two weeks after polypectomy
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Complete retrieval rate of colorectal polyps
Description
The complete retrieval rate of colorectal polyps based on the pathological examination.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, MD
Organizational Affiliation
Showa Inan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24125514
Citation
Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
Results Reference
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Prospective Comparison of Cold Polypectomy and Conventional Polypectomy for Small Colorectal Polyps in Patients Taking Antithrombotic Agents

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