The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
NCT ID: NCT01179750
Last Updated: 2010-12-16
Study Results
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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UNKNOWN
PHASE3
256 participants
INTERVENTIONAL
2010-01-31
2011-06-30
Brief Summary
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In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.
The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.
The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No Ultrasonic Coagulating Shears group
the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;
No interventions assigned to this group
ultrasonic coagulation shears group
the other arm: operated group using ultrasonic coagulation shears during gastrectomy
Ultrasonic Coagulating Shears
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Interventions
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Ultrasonic Coagulating Shears
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient who agrees to participate in this study by signing the informed consent form
Exclusion Criteria
* Have simultaneously other cancer
* Underwent cancer therapy at past time
* Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
* Have a previous upper gastrointestinal surgery
20 Years
75 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center, Sungkyunkwan University School of Medicine
Principal Investigators
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Jae Moon Bae, MD., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, Sungkyunkwan University
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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JaeMoon Bae, MD.,Ph.D.
Role: primary
SeungJong Oh, MD
Role: backup
References
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Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002 Feb;26(2):158-61. doi: 10.1007/s00268-001-0199-9. Epub 2001 Dec 4.
Other Identifiers
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2009-08-089
Identifier Type: -
Identifier Source: org_study_id