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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01126060
First received: April 15, 2010
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Thyroid Carcinoma
Thyroidectomy
Drug: Usage of Fibrin sealant
Procedure: Thyroidectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Postoperative Drainage Amount [ Time Frame: serial measurement from 1day to 4day after surgery ] [ Designated as safety issue: No ]
    method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL


Enrollment: 78
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01126060

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

No publications provided

Responsible Party: Man Ki Chung/Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126060     History of Changes
Other Study ID Numbers: 2009-12-093
Study First Received: April 15, 2010
Results First Received: September 6, 2011
Last Updated: November 15, 2011
Health Authority: South Korea: Institutional Review Board

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014