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

Thyroidectomy Clinical Trial

Official title:

Efficacy of Fibrin Sealant to Reduce the Amount of Postoperative Drain in Patients With Harmonic Scalpel-assisted Total Thyroidectomy With Anterior Compartment Neck Dissections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126060
• Other study ID #: 2009-12-093
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2010
• Last updated: November 15, 2011
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Carcinoma
• Thyroid Neoplasms
• Thyroidectomy

Intervention

Drug:
• Usage of Fibrin sealant
Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection

Procedure:
• Thyroidectomy
surgical removal of bilateral thyroid glands

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Drainage Amount	method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL	serial measurement from 1day to 4day after surgery	No