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

Showa Inan General Hospital

Status: Completed

Conditions: Colorectal Polyps

Treatments: Procedure: Cold polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01553565

cold vs.hot

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Conventional polypectomy

Active Comparator group

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.

Treatment:

Procedure: Cold polypectomy

Cold polypectomy

Experimental group

Treatment:

Procedure: Cold polypectomy