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

NCT ID: NCT01553565

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Colorectal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cold polypectomy

Intervention Type PROCEDURE

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.

Cold polypectomy

Group Type EXPERIMENTAL

Cold polypectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Cold snare polypectomy

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Akira Horiuchi

Chief, Digestive Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akira Horiuchi, MD

Role: PRINCIPAL_INVESTIGATOR

Showa Inan General Hospital

Locations

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Showa Inan General Hospital

Komagane, Nagano, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 24125514 (View on PubMed)

Other Identifiers

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cold vs.hot

Identifier Type: -

Identifier Source: org_study_id

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