Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

Study Overview
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Brief Summary
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To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat comparing postoperative CRP level in each group

Detailed Description
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To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat comparing postoperative CRP level in each group post operative 2nd day CRP level post operative 4th day CRP level post operative IL-6, 10 level in 2nd, 4th day

Official Title
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Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer

Conditions
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Postoperative Inflammation, Postoperative Fever

Intervention / Treatment
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* Device: ULTRACISION Harmonic Scalpel
* Device: Ligasure Maryland
* Device: Thunderbeat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically proven adenocarcinoma in stomach patients who are expected for R0 resection with distal gastrectomy pre-operative clinical stage should be stage I patients who is able to be followed up with in postoperative 30 days patients whose CRP is normal before surgery Exclusion Criteria: patients who had an abdominal surgery patients who received chemotherapy, radiotherapy before surgery patients who received ESD before surgery Patietns who had an ascites on pre-operative CT scan liver cirrhosis cardiovascular disease (Ejection Fraction<50%) serum creatinine > 1.4 mg/dL or BUN>26mg/dL PT INR >1.2 or aPTT>45sec uncontrolle diabetes Crohn's disease, ulcerative colitis patients who receives anti-coagulants patients who need pre-operative steroid booster because of steroid treatment pregnancy patients who have allergic reaction to iodine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ULTRACISION Harmonic Scalpel<br>Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy | Device: ULTRACISION Harmonic Scalpel<br>* to use ULTRACISION Harmonic Scalpel when performing gastrectomy<br>|
| Experimental: Ligasure Maryland<br>Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy | Device: Ligasure Maryland<br>* to use Ligasure Maryland when performing gastrectomy<br>|
| Experimental: Thunderbeat<br>Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy | Device: Thunderbeat<br>* to use Thunderbeat when performing gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative 2nd day CRP | To check the postoperative 2nd day CRP level in each group | 2nd day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative 4th day CRP | To check the postoperative 4th day CRP level in each group | 4th day | 
| postoperative IL-6, IL10 level | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | 2nd, 4th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fever, inflammation