Phase 3
N=80
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
Thyroid Carcinoma · Thyroidectomy
Bottom Line
View on ClinicalTrials.gov: NCT01126060 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Postoperative Drainage Amount — 93.5; 105.7 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Usage of Fibrin sealant (Drug); Thyroidectomy (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Samsung Medical Center
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Drainage Amount |
93.5; 105.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01126060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.