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Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin sealant | Active Comparator | usage of fibrin sealant after surgery |
|
| Control | No Intervention | No usage of fibrin sealant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usage of Fibrin sealant | Drug | Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Drainage Amount | method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL | serial measurement from 1day to 4day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 135-710 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibrin Sealant | drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) |
| FG001 | No Fibrin Sealant | No usage of fibrin sealant No usage of alternative drugs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibrin Sealant | drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) |
| BG001 | No Fibrin Sealant | No usage of fibrin sealant No usage of alternative drugs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Drainage Amount | method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL | Posted | Mean | Standard Deviation | mL | serial measurement from 1day to 4day after surgery |
|
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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 | Fibrin Sealant | drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) |
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realtive small number of patients to retrieve significant difference between two groups
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Man Ki Chung | Samsung medical center | 82-2-3410-1845 | manki.chung@samsung.com |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013965 | Thyroidectomy |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Thyroidectomy | Procedure | surgical removal of bilateral thyroid glands |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | No Fibrin Sealant | No usage of fibrin sealant No usage of alternative drugs | 0 | 40 | 0 | 40 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |