Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
NCT ID: NCT03356626
Last Updated: 2024-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
189 participants
INTERVENTIONAL
2018-03-12
2022-08-22
Brief Summary
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comparing postoperative CRP level in each group
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Detailed Description
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comparing postoperative CRP level in each group
1. post operative 2nd day CRP level
2. post operative 4th day CRP level
3. post operative IL-6, 10 level in 2nd, 4th day
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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ULTRACISION Harmonic Scalpel
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
ULTRACISION Harmonic Scalpel
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
Ligasure Maryland
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
Ligasure Maryland
to use Ligasure Maryland when performing gastrectomy
Thunderbeat
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy
Thunderbeat
to use Thunderbeat when performing gastrectomy
Interventions
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ULTRACISION Harmonic Scalpel
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
Ligasure Maryland
to use Ligasure Maryland when performing gastrectomy
Thunderbeat
to use Thunderbeat when performing gastrectomy
Eligibility Criteria
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Inclusion Criteria
* 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 received chemotherapy, radiotherapy before surgery
* patients who received ESD before surgery
* Patients 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
* uncontrolled 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
20 Years
80 Years
ALL
Yes
Sponsors
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Medtronic Spine LLC
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Seong-Ho Kong, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EBD-02
Identifier Type: -
Identifier Source: org_study_id
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