Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer
NCT ID: NCT01742806
Last Updated: 2012-12-05
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
NA
120 participants
INTERVENTIONAL
2012-10-31
2013-06-30
Brief Summary
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Detailed Description
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This study is an randomised controlled trial undertaken in 7 centers in South Korea. Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.
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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control
not to use bio-absorbable felt(NEOVEIL®)
No interventions assigned to this group
NEOVEIL®
To use bio-absorbable felt
bio-absorbable felt(NEOVEIL®)
To cover bio-absorbable felt over the lymphadenectomy area (hepatoduodenal ligament, #5 and 12/gastroduodenal artery, #6/ pancreas head /suprapancreatic area, #7,8 and 9)
Interventions
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bio-absorbable felt(NEOVEIL®)
To cover bio-absorbable felt over the lymphadenectomy area (hepatoduodenal ligament, #5 and 12/gastroduodenal artery, #6/ pancreas head /suprapancreatic area, #7,8 and 9)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who underwent laparoscopic distal gastrectomy.
* preoperative clinical stage I diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography.
* patients who underwent more than D1+b lymphadenectomy
Exclusion Criteria
* liver or renal disease (Ex. liver cirrhosis, end stage renal disease)
* Transfusion is needed preoperatively or postoperatively due to bleeding
* Preoperative or intraoperative evaluation confirm ascites.
* Patients who use anticoagulant preoperatively or postoperatively
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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WOO JIN HYUNG, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Seoul National University College of Medicine, Bundang Hospital
Seongnam-si, Gyenggi-do, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Soonchunhyang University College of Medicine, Bucheon Hospital
Bucheon-si, , South Korea
Dong-A University College of Medicine
Busan, , South Korea
Seoul National University College of Medicine, Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hyung-Ho Kim, M.D., Ph.D.
Role: primary
Sang-Uk Han, M.D., Ph.D.
Role: primary
Gyu Seok Cho, M.D., Ph.D.
Role: primary
Min-Chan Kim, M.D., Ph.D.
Role: primary
Hyuk-Joon Lee, M.D., Ph.D.
Role: primary
WOOK KIM, M.D. Ph.D.
Role: primary
WOO JIN HYUNG, M.D., Ph.D.
Role: primary
References
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Nakamura T, Shimizu Y, Watanabe S, Hitomi S, Kitano M, Tamada J, Matsunobe S. New bioabsorbable pledgets and non-woven fabrics made from polyglycolide (PGA) for pulmonary surgery: clinical experience. Thorac Cardiovasc Surg. 1990 Apr;38(2):81-5. doi: 10.1055/s-2007-1013999.
Hayashibe A, Sakamoto K, Shinbo M, Makimoto S, Nakamoto T. New method for prevention of bile leakage after hepatic resection. J Surg Oncol. 2006 Jul 1;94(1):57-60. doi: 10.1002/jso.20548.
Ueda K, Tanaka T, Li TS, Tanaka N, Hamano K. Sutureless pneumostasis using bioabsorbable mesh and glue during major lung resection for cancer: who are the best candidates? J Thorac Cardiovasc Surg. 2010 Mar;139(3):600-5. doi: 10.1016/j.jtcvs.2009.06.021. Epub 2009 Aug 4.
Other Identifiers
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1-2012-0017
Identifier Type: -
Identifier Source: org_study_id