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| Name | Class |
|---|---|
| Medtronic Spine LLC | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ULTRACISION Harmonic Scalpel | Experimental | Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy |
|
| Ligasure Maryland | Experimental | Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy |
|
| Thunderbeat | Experimental | Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ULTRACISION Harmonic Scalpel | Device | to use ULTRACISION Harmonic Scalpel when performing gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative 2nd Day CRP | To check the postoperative 2nd day CRP level in each group | 2nd day |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative 4th Day CRP | To check the postoperative 4th day CRP level in each group | 4th day |
| Postoperative 2nd Day IL-6 | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong-Ho Kong, MD,PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Ligasure Maryland | Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy |
| FG002 | Thunderbeat | Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ligasure Maryland |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative 2nd Day CRP | To check the postoperative 2nd day CRP level in each group | Posted | Mean | Standard Deviation | mg/dL | 2nd day |
|
30 days after operation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative complication: Clavien-Dindo grade < IIIa | Gastrointestinal disorders | Systematic Assessment |
The complication rate, could not be evaluated due to the limited number of cases. A stratified randomization method was chosen in this study to prevent an imbalance of prognostic factors that could affect the results, but the baseline characteristics of the patients in each group were not perfectly balanced. Since gastric surgery may be affected by patient factors, such as sex and BMI, those factors should be considered stratification factors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seong-Ho Kong | Seoul National University Hospital, Seoul National University College of Medicine | +82-2-2072-4199 | seongho.kong@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2021 | May 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Ligasure Maryland | Device | to use Ligasure Maryland when performing gastrectomy |
|
| Thunderbeat | Device | to use Thunderbeat when performing gastrectomy |
|
| 2nd day |
| Postoperative 4th Day IL-6 | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | 4th day |
| Postoperative 2nd Day IL-10 Level | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | 2nd day |
| Postoperative 4th Day IL-10 Level | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | 4th day |
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy |
| BG002 | Thunderbeat | Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preoperative CRP level | Mean | Standard Deviation | mg/dL |
|
| Thunderbeat |
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy |
|
|
| Secondary | Postoperative 4th Day CRP | To check the postoperative 4th day CRP level in each group | Posted | Mean | Standard Deviation | mg/dL | 4th day |
|
|
|
| Secondary | Postoperative 2nd Day IL-6 | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | Posted | Mean | Standard Deviation | pg/ml | 2nd day |
|
|
|
| Secondary | Postoperative 4th Day IL-6 | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | Posted | Mean | Standard Deviation | pg/ml | 4th day |
|
|
|
| Secondary | Postoperative 2nd Day IL-10 Level | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | Posted | Mean | Standard Deviation | pg/ml | 2nd day |
|
|
|
| Secondary | Postoperative 4th Day IL-10 Level | To check the postoperative 2nd, 4th day IL-6, IL10 level in each group | Posted | Mean | Standard Deviation | pg/ml | 4th day |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 2 |
| 57 |
| EG001 | Ligasure Maryland | Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy | 0 | 60 | 0 | 60 | 3 | 60 |
| EG002 | Thunderbeat | Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy | 0 | 57 | 0 | 57 | 4 | 57 |
| Postoperative complication: Clavien-Dindo grade ≥ IIIa † | Gastrointestinal disorders | Systematic Assessment |
|
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