A Phase 3 interventional study of Usage of Fibrin sealant and Thyroidectomy in Thyroid Carcinoma and Thyroidectomy, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-19.
Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment
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.
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's enrollment of 78 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
usage of fibrin sealant after surgery
Drug: Usage of Fibrin sealant · Procedure: Thyroidectomy
No usage of fibrin sealant
Procedure: Thyroidectomy
Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection
surgical removal of bilateral thyroid glands
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
| Milestone | Fibrin Sealant | No Fibrin Sealant |
|---|---|---|
| Started | 40 | 40 |
| Completed | 40 | 38 |
| Not completed | 0 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
| mL | Fibrin Sealant | No Fibrin Sealant |
|---|---|---|
| Postoperative Drainage Amount | 93.5 ± 30.7 | 105.7 ± 31.2 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibrin Sealant | — | 0/38 (0%) | 0/38 (0%) |
| No Fibrin Sealant | — | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Fibrin Sealant | No Fibrin Sealant | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 40 | 80 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Fibrin Sealant | No Fibrin Sealant | Total |
|---|---|---|---|
| Mean | 47.8 ± 9.6 | 50.8 ± 10.8 | 49.3 ± 10.3 |
| Sex: Female, Male(Participants) | Fibrin Sealant | No Fibrin Sealant | Total |
|---|---|---|---|
| Female | 34 | 27 | 61 |
| Male | 6 | 13 | 19 |
| Region of Enrollment(participants) | Fibrin Sealant | No Fibrin Sealant | Total |
|---|---|---|---|
| Korea, Republic of | 40 | 40 | 80 |
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center