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

Colorectal Polyps Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553565
• Other study ID #: cold vs.hot
• Status: Completed
• Phase: N/A
• First received: March 10, 2012
• Last updated: August 13, 2014
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Colorectal Polyps

Intervention

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.

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpolypectomy bleeding	Bleeding within two weeks after polypectomy	2 weeks	Yes
Secondary	Complete retrieval rate of colorectal polyps	The complete retrieval rate of colorectal polyps based on the pathological examination.	2 weeks	No