The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery

Study Overview
=================
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.

Official Title
-----------------
The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery

Conditions
-----------------
Stomach Cancer, Gastrectomy, Ultrasonic Coagulating Shears

Intervention / Treatment
-----------------
* Device: Ultrasonic Coagulating Shears


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Ultrasonic Coagulating Shears group<br>the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy; | |
| Experimental: ultrasonic coagulation shears group<br>the other arm: operated group using ultrasonic coagulation shears during gastrectomy | Device: Ultrasonic Coagulating Shears<br>* comparison of operated groups between with Ultrasonic Coagulating Shears and without them.<br>* Other names: Harmonic Ace;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital | 2 weeks later after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonic coagulating shears in gastrectomy