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Completed

NCT Number: NCT01126060

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

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.

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Key information

Conditions

Thyroid Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroidectomy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usage of Fibrin sealant

Drug

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

Thyroidectomy

Procedure

surgical removal of bilateral thyroid glands

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 19, 2010
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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