- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356626
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
March 23, 2023 updated by: Seoul National University Hospital
Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Actual)
189
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Seong-Ho Kong, MD.PhD
- Phone Number: +82-2072-4199
- Email: wisehearted@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ULTRACISION Harmonic Scalpel
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
|
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Experimental: Ligasure Maryland
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
|
to use Ligasure Maryland when performing gastrectomy
|
Experimental: Thunderbeat
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy
|
to use Thunderbeat when performing gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative 2nd day CRP
Time Frame: 2nd day
|
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
Time Frame: 4th day
|
To check the postoperative 4th day CRP level in each group
|
4th day
|
postoperative IL-6, IL10 level
Time Frame: 2nd, 4th day
|
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
|
2nd, 4th day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Seong-Ho Kong, MD,PhD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2018
Primary Completion (Actual)
January 7, 2021
Study Completion (Actual)
August 22, 2022
Study Registration Dates
First Submitted
November 24, 2017
First Submitted That Met QC Criteria
November 24, 2017
First Posted (Actual)
November 29, 2017
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBD-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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