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

NCT ID: NCT01126060

Last Updated: 2011-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Carcinoma Thyroidectomy

Keywords

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Neck dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fibrin sealant

usage of fibrin sealant after surgery

Group Type ACTIVE_COMPARATOR

Usage of Fibrin sealant

Intervention Type DRUG

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

Thyroidectomy

Intervention Type PROCEDURE

surgical removal of bilateral thyroid glands

Control

No usage of fibrin sealant

Group Type NO_INTERVENTION

Thyroidectomy

Intervention Type PROCEDURE

surgical removal of bilateral thyroid glands

Interventions

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Usage of Fibrin sealant

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

Intervention Type DRUG

Thyroidectomy

surgical removal of bilateral thyroid glands

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009-12-093

Identifier Type: -

Identifier Source: org_study_id