The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Recruitment status was Recruiting
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.
Ultrasonic Coagulating Shears
Device: Ultrasonic Coagulating Shears
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery|
- operation time [ Time Frame: 2 weeks later after operation ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]amount of blood loss: an amount of blood loss during operation time
- C-reactive protein [ Time Frame: post operative day #0, #1, #5 ] [ Designated as safety issue: No ]
- total lymphocyte count [ Time Frame: post operative day #0, #1, #5 ] [ Designated as safety issue: No ]
- postoperative complications [ Time Frame: 4 weeks later after operation ] [ Designated as safety issue: Yes ]
- drainage from peritoneal cavity during hospital [ Time Frame: 2 weeks later after operation ] [ Designated as safety issue: No ]amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179750
|Contact: Jae Moon Bae, Professorfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: JaeMoon Bae, MD.,Ph.D. 82-2-3410-0252 email@example.com|
|Contact: SeungJong Oh, MD 82-2-3410-1735 firstname.lastname@example.org|
|Principal Investigator:||Jae Moon Bae, MD., Ph.D.||Samsung Medical Center, Sungkyunkwan University|