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

NCT01553565 | Completed

• 1 other identifier: cold vs.hot
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Background: The ideal method to remove small colorectal polyps in patients who are taking antithrombotic agents is unknown.
2. 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. 3.Design: A prospective, consecutive study.
4. 4.Setting: Municipal hospital outpatients.
5. 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.

Conditions

Colorectal Polyps

Keywords

10 mm in diameter; antithrombotic agents

Outcome Measures

Primary Outcomes (1)

• Postpolypectomy bleeding

  Bleeding within two weeks after polypectomy

  2 weeks

Secondary Outcomes (1)

• Complete retrieval rate of colorectal polyps

  2 weeks

Study Arms (2)

Conventional polypectomy

ACTIVE COMPARATOR

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.

Procedure: Cold polypectomy

Cold polypectomy

EXPERIMENTAL

Procedure: Cold polypectomy

Interventions

Cold polypectomy 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.

Also known as: Cold snare polypectomy

Cold polypectomy; Conventional polypectomy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with colorectal polyps up to 10 mm in diameter. The patients continue to take antithrombotic agents.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

Related Publications (1)

• 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.

  PMID: 24125514 DERIVED

Study Officials

• Akira Horiuchi, MD

  Showa Inan General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Digestive Disease Center

Study Record Dates

• First Submitted: March 10, 2012
• First Posted: March 14, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

JP (1)