The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT01179750|
Recruitment Status : Unknown
Verified December 2010 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : August 11, 2010
Last Update Posted : December 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Cancer Gastrectomy Ultrasonic Coagulating Shears||Device: Ultrasonic Coagulating Shears||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||June 2011|
No Intervention: No Ultrasonic Coagulating Shears group
the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;
Experimental: ultrasonic coagulation shears group
the other arm: operated group using ultrasonic coagulation shears during gastrectomy
Device: Ultrasonic Coagulating Shears
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Other Name: Harmonic Ace
- operation time [ Time Frame: 2 weeks later after operation ]operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
- amount of blood loss [ Time Frame: 2 weeks later after operation ]amount of blood loss: an amount of blood loss during operation time
- C-reactive protein [ Time Frame: post operative day #0, #1, #5 ]
- total lymphocyte count [ Time Frame: post operative day #0, #1, #5 ]
- postoperative complications [ Time Frame: 4 weeks later after operation ]
- drainage from peritoneal cavity during hospital [ Time Frame: 2 weeks later after operation ]amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179750
|Contact: Jae Moon Bae, Professoremail@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: JaeMoon Bae, MD.,Ph.D. 82-2-3410-0252 firstname.lastname@example.org|
|Contact: SeungJong Oh, MD 82-2-3410-1735 email@example.com|
|Principal Investigator:||Jae Moon Bae, MD., Ph.D.||Samsung Medical Center, Sungkyunkwan University|