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

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ClinicalTrials.gov Identifier: NCT01126060
Recruitment Status : Completed
First Posted : May 19, 2010
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Thyroid Carcinoma Thyroidectomy Drug: Usage of Fibrin sealant Procedure: Thyroidectomy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: Fibrin sealant
usage of fibrin sealant after surgery
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
No Intervention: Control
No usage of fibrin sealant
Procedure: Thyroidectomy
surgical removal of bilateral thyroid glands



Primary Outcome Measures :
  1. Postoperative Drainage Amount [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126060


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Man Ki Chung/Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126060     History of Changes
Other Study ID Numbers: 2009-12-093
First Posted: May 19, 2010    Key Record Dates
Results First Posted: December 19, 2011
Last Update Posted: December 19, 2011
Last Verified: November 2011

Keywords provided by Samsung Medical Center:
Neck dissection

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants