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OpenTrials
Completed

NCT Number: NCT01646242

Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.

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Key information

Conditions

Polyp of Large Intestine

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyunghee University Medical Center

Seoul, 130-702, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over the age of 20
  • Informed consent

Exclusion criteria

  • Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
  • Known existing bleeding tendency (thrombocytopenia or prolonged INR)
  • Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
  • ASA class III or more
  • Pregnancy
  • Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Treatment and study plan

removal of eligible polyps using cold snare polypectomy technique

Procedure

Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery

removal of eligible polyps using double biopsy technique

Procedure

Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)

Primary outcomes

  1. Complete histologic polyp eradication rate

    Time frame: 2 weeks

Secondary outcomes

  1. Time taken for polypectomy (complete visual eradication of each polyp)

    Time frame: 2 weeks

    time from polyp resection to tissue retrieval

  2. Successful tissue retrieval rate of removed tissues

    Time frame: 2 weeks

  3. Rates of adverse events

    Time frame: 4 weeks

    Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).

  4. Complete visual polyp eradication rate

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study title

Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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