Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Man Ki Chung/Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126060    
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:
Layout table for 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