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

Phase 3

Completed

• Conditions: Thyroid Carcinoma; Thyroidectomy
• Interventions: Drug: Usage of Fibrin sealant; Procedure: Thyroidectomy

• Registration Number: NCT01126060
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-09-06
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Results First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin sealant	Usage of Fibrin sealant	usage of fibrin sealant after surgery
Fibrin sealant	Thyroidectomy	usage of fibrin sealant after surgery
Control	Thyroidectomy	No usage of fibrin sealant

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of