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This study is to evaluate if Bio-absorbable Felt(NEOVEILĀ®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.
We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEILĀ®) after D1+b or D2 lymphadenectomy with distal gastrectomy for early gastric cancer.
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(NEOVEILĀ®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | not to use bio-absorbable felt(NEOVEILĀ®) | |
| NEOVEILĀ® | Experimental | To use bio-absorbable felt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bio-absorbable felt(NEOVEILĀ®) | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to drain removal | Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding. | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| total amount of exudate drainage | Total amount of exudate after surgery is recorded. | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge after surgery and postoperative complication | Time to discharge after surgery and postoperative complication are recorded | up to 30days after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WOO JIN HYUNG, M.D. Ph.D. | Contact | 82-2-2228-2129 | wjhyung@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| WOO JIN HYUNG, M.D. Ph.D. | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University College of Medicine, Bundang Hospital | Recruiting | Seongnam-si | Gyenggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2161571 | Background | 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. | |
| 16788945 | Background | 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. |
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|
| Ajou University Medical Center | Recruiting | Suwon | Gyeonggi-do | South Korea |
|
| Soonchunhyang University College of Medicine, Bucheon Hospital | Recruiting | Bucheon-si | South Korea |
|
| Dong-A University College of Medicine | Recruiting | Busan | South Korea |
|
| Seoul National University College of Medicine, Seoul National University Hospital | Not yet recruiting | Seoul | South Korea |
|
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Recruiting | Seoul | South Korea |
|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
|
| 19656529 | Background | 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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