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The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506103
First Posted: July 25, 2007
Last Update Posted: July 26, 2007
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.
Information provided by:
Soonchunhyang University Hospital
  Purpose
To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.

Condition
Hemorrhage Hypocalcemia Vocal Cord Palsy

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Further study details as provided by Soonchunhyang University Hospital:

Study Start Date: October 2006
Study Completion Date: June 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with total thyroidectomy plus central neck dissection
  • if primary tumor size was more than 1 cm in papillary thyroid cancer
  • there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively
  • patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer

Exclusion Criteria:

  • patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis
  • patients had clinical or laboratory indicators of coagulation disorders
  • patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve
  • patients with massive extracapsular extension to the surrounding soft tissues.
  Contacts and Locations
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): NCT00506103


Locations
Korea, Republic of
Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
Bucheon, Korea, Republic of
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Yoon Woo Koh, MD Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00506103     History of Changes
Other Study ID Numbers: SCHHN
First Submitted: July 21, 2007
First Posted: July 25, 2007
Last Update Posted: July 26, 2007
Last Verified: July 2007

Keywords provided by Soonchunhyang University Hospital:
Thyroidectomy
Central neck dissection
Harmonic scalpel
Perioperative complications

Additional relevant MeSH terms:
Vocal Cord Paralysis
Hemorrhage
Hypocalcemia
Pathologic Processes
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms