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

NCT ID: NCT02036047

Last Updated: 2014-11-04

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diminutive Colorectal Polyp Cold Snare Polypectomy Polypectomy Snare Complete Resection Rate Postpolypectomy Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Regular polypectomy snare (Snare Master, SD-210U-10)

Intervention Type DEVICE

Interventions

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exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)

Intervention Type DEVICE

Regular polypectomy snare (Snare Master, SD-210U-10)

Intervention Type DEVICE

Eligibility Criteria

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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.
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

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, Hosoi K, Kajiyama M, Tanaka N, Sano K, Graham DY. Prospective, randomized comparison of 2 methods of cold snare polypectomy for small colorectal polyps. Gastrointest Endosc. 2015 Oct;82(4):686-92. doi: 10.1016/j.gie.2015.02.012. Epub 2015 Apr 25.

Reference Type DERIVED
PMID: 25922251 (View on PubMed)

Other Identifiers

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Exacto

Identifier Type: -

Identifier Source: org_study_id

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