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

This study has been completed.
Information provided by:
Soonchunhyang University Hospital Identifier:
First received: July 21, 2007
Last updated: July 25, 2007
Last verified: July 2007
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.

Vocal Cord Palsy

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Further study details as provided by Soonchunhyang University Hospital:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00506103

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
Principal Investigator: Yoon Woo Koh, MD Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
  More Information

Publications: Identifier: NCT00506103     History of Changes
Other Study ID Numbers: SCHHN
Study First Received: July 21, 2007
Last Updated: July 25, 2007
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Vocal Cord Paralysis
Calcium Metabolism Disorders
Cranial Nerve Diseases
Laryngeal Diseases
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms
Vagus Nerve Diseases
Water-Electrolyte Imbalance processed this record on November 27, 2015