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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Ultrasonic Coagulating Shears group | No Intervention | the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy; | |
| ultrasonic coagulation shears group | Experimental | the other arm: operated group using ultrasonic coagulation shears during gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic Coagulating Shears | Device | comparison of operated groups between with Ultrasonic Coagulating Shears and without them. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | post operative day #0, #1, #5 | |
| total lymphocyte count | post operative day #0, #1, #5 | |
| postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Moon Bae, Professor | Contact | +82-2-3410-0252 | jmoon.bae@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Jae Moon Bae, MD., Ph.D. | Samsung Medical Center, Sungkyunkwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11865342 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 31, 2011 | |
| Reset | Aug 29, 2011 | |
| Release | Jun 7, 2012 | |
| Reset | Jul 9, 2012 | |
| Release | Mar 16, 2021 | |
| Reset | Apr 8, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 31, 2011 | Aug 29, 2011 | |||
| Jun 7, 2012 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 4 weeks later after operation |
| drainage from peritoneal cavity during hospital | amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital | 2 weeks later after operation |
| Jul 9, 2012 |
| Mar 16, 2021 | Apr 8, 2021 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |