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Compare Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT03373136
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
In this randomized control trial the investigators aim to compare the bleeding complication between cold snaring and hot snaring polypectomy with a large sample size.

Condition or disease Intervention/treatment Phase
Colorectal Polyp Device: Polypectomy Not Applicable

Detailed Description:
The investigators will enroll subjects who receive screening or surveillance colonoscopy with small colorectal polyp, 4 to10 mm in size, from multiple centers in Taiwan. Subjects who are less than 20 years old and has contraindication will be excluded from this study. All the candidates for enrollment will sign the inform consent at the outpatient clinic. Once the candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy will be randomized into either cold snaring or hot snaring polypectomy group. In the group with cold snaring, polypectomy will be done without electrocautery. In the hot snaring group, the polypectomy will be performed with electrocautery. The bowel preparation and colonoscopy insertion are the same in both groups as conventional colonoscopy method. The colonoscopy will be performed by experienced endoscopies who performed more than 100 polypectomies per year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Cold snaring
Polypectomy will be done without electrocautery
Device: Polypectomy
Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer

Active Comparator: Hot snaring
Polypectomy will be performed with electrocautery
Device: Polypectomy
Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer




Primary Outcome Measures :
  1. Delayed bleeding rate [ Time Frame: 2 weeks ]
    Anal bleeding with spontaneously stop; drop of Hb more than 2 gm/dl in comparison with baseline; transfusion needed; hemostasis by : colonoscopy, angiography, surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy

Exclusion Criteria:

  • Subjects who are less than 20 years old and has contraindication will be excluded from this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373136


Contacts
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Contact: Li-Chun Chang, MD, MSc 886-2-23123456 ext 63863 lichunchang@ntu.edu.tw

Locations
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Taiwan
Department of Internal Medicine, College of Medicine, National Taiwan University Recruiting
Taipei, Taiwan, 100
Contact: Li-Chun Chang, MD, MSc    886-2-23123456 ext 63863    lichunchang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Han-Mo CHIU, M.D., Ph.D. Department of Internal Medicine, College of Medicine, National Taiwan University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03373136     History of Changes
Other Study ID Numbers: 201707022RINB
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical