Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Thyroid Carcinoma; Thyroidectomy

Treatments: Procedure: Thyroidectomy; Drug: Usage of Fibrin sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT01126060

2009-12-093

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Fibrin sealant

Active Comparator group

Description:

usage of fibrin sealant after surgery

Treatment:

Procedure: Thyroidectomy

Drug: Usage of Fibrin sealant

Control

No Intervention group

Description:

No usage of fibrin sealant

Treatment:

Procedure: Thyroidectomy