The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps

November 2, 2014 updated by: Akira Horiuchi, Showa Inan General Hospital
The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4117
        • Showa Inan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with colorectal polyps up to 10 mm in diameter.

Exclusion Criteria:

  • patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical resection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exclusive cold polypectomy snare
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using an exclusive cold polypectomy snare (Exacto cold snare). The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy.
Device: exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)
Active Comparator: regular polypectomy snare
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using a regular polypectomy snare. The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy.
Device: Regular polypectomy snare (Snare Master, SD-210U-10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete resection rate of colorectal polyps
Time Frame: 2 weeks
The complete resection rate of colorectal polyps based on the pathological examination.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpolypectomy bleeding
Time Frame: 2 weeks
Postpolypectomy bleeding within two weeks after cold snare polypectomy
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The procedure time
Time Frame: 1 day
The procedure time spent for cold snare polypectomy
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 11, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 2, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exacto

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postpolypectomy Bleeding

Clinical Trials on exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe