Thyroid Carcinoma, Thyroidectomy
Conditions
Keywords
Neck dissection
Brief summary
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.
Interventions
DRUGUsage of Fibrin sealant
Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection
PROCEDUREThyroidectomy
surgical removal of bilateral thyroid glands
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* proven thyroid carcinoma * Thyroidectomy with anterior compartment neck dissection
Exclusion criteria
* No use of harmonic scalpel during surgery * coagulation abnormality * refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Drainage Amount | serial measurement from 1day to 4day after surgery | method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibrin Sealant drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) | 40 |
| No Fibrin Sealant No usage of fibrin sealant No usage of alternative drugs | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | No Fibrin Sealant | Fibrin Sealant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age Continuous | 50.8 years STANDARD_DEVIATION 10.8 | 47.8 years STANDARD_DEVIATION 9.6 | 49.3 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Korea, Republic of | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 27 Participants | 34 Participants | 61 Participants |
| Sex: Female, Male Male | 13 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 |
Outcome results
Primary
Postoperative Drainage Amount
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
Time frame: serial measurement from 1day to 4day after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibrin Sealant | Postoperative Drainage Amount | 93.5 mL | Standard Deviation 30.7 |
| No Fibrin Sealant | Postoperative Drainage Amount | 105.7 mL | Standard Deviation 31.2 |