The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
1 other identifier
interventional
256
1 country
1
Brief Summary
Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears . 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 16, 2010
December 1, 2010
1.2 years
July 27, 2010
December 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
operation time
operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
2 weeks later after operation
amount of blood loss
amount of blood loss: an amount of blood loss during operation time
2 weeks later after operation
Secondary Outcomes (4)
C-reactive protein
post operative day #0, #1, #5
total lymphocyte count
post operative day #0, #1, #5
postoperative complications
4 weeks later after operation
drainage from peritoneal cavity during hospital
2 weeks later after operation
Study Arms (2)
No Ultrasonic Coagulating Shears group
NO INTERVENTIONthe one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;
ultrasonic coagulation shears group
EXPERIMENTALthe other arm: operated group using ultrasonic coagulation shears during gastrectomy
Interventions
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Eligibility Criteria
You may qualify if:
- Patients with the diagnosis of gastric cancer
- The patient who agrees to participate in this study by signing the informed consent form
You may not qualify if:
- The patient who refuse to participate in this study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
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.
PMID: 11865342BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Moon Bae, MD., Ph.D.
Samsung Medical Center, Sungkyunkwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 27, 2010
First Posted
August 11, 2010
Study Start
January 1, 2010
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
December 16, 2010
Record last verified: 2010-12