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

Not Applicable

Completed

• Conditions: Colorectal Polyps
• Interventions: Procedure: Cold polypectomy

• Registration Number: NCT01553565
• Lead Sponsor: Showa Inan General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-10
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional polypectomy	Cold 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.
Cold polypectomy	Cold polypectomy	-

Primary Outcome Measures

Name	Time	Method
Postpolypectomy bleeding	2 weeks	Bleeding within two weeks after polypectomy

Secondary Outcome Measures

Name	Time	Method
Complete retrieval rate of colorectal polyps	2 weeks	The complete retrieval rate of colorectal polyps based on the pathological examination.

Trial Locations

Locations (1)

Showa Inan General Hospital; 🇯🇵 Komagane, Nagano, Japan