Gastrectomy, Stomach Cancer, Ultrasonic Coagulating Shears
Conditions
Keywords
Ultrasonic coagulating shears in gastrectomy
Brief summary
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.
Interventions
DEVICEUltrasonic Coagulating Shears
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with the diagnosis of gastric cancer * The patient who agrees to participate in this study by signing the informed consent form
Exclusion criteria
* The patient who refuse to participate in this study * Have simultaneously other cancer * Underwent cancer therapy at past time * Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis) * Have a previous upper gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operation time | 2 weeks later after operation | operation time: a time from the opening of peritoneal cavity to the retrieval of specimen |
| amount of blood loss | 2 weeks later after operation | amount of blood loss: an amount of blood loss during operation time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | post operative day #0, #1, #5 | — |
| total lymphocyte count | post operative day #0, #1, #5 | — |
| postoperative complications | 4 weeks later after operation | — |
| drainage from peritoneal cavity during hospital | 2 weeks later after operation | amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital |
Countries
South Korea
Contacts
Primary ContactJae Moon Bae, Professor
Outcome results
None listed