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

Primary Purpose

Thyroid Carcinoma, Thyroidectomy

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Usage of Fibrin sealant
Thyroidectomy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Carcinoma focused on measuring Neck dissection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Fibrin sealant

Control

Arm Description

usage of fibrin sealant after surgery

No usage of fibrin sealant

Outcomes

Primary Outcome Measures

Postoperative Drainage Amount
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL

Secondary Outcome Measures

Full Information

First Posted
April 15, 2010
Last Updated
November 15, 2011
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01126060
Brief Title
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Thyroidectomy
Keywords
Neck dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrin sealant
Arm Type
Active Comparator
Arm Description
usage of fibrin sealant after surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
No usage of fibrin sealant
Intervention Type
Drug
Intervention Name(s)
Usage of Fibrin sealant
Intervention Description
Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection
Intervention Type
Procedure
Intervention Name(s)
Thyroidectomy
Intervention Description
surgical removal of bilateral thyroid glands
Primary Outcome Measure Information:
Title
Postoperative Drainage Amount
Description
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
Time Frame
serial measurement from 1day to 4day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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