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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:
Information provided by:
Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT00506103
First received: July 21, 2007
Last updated: July 25, 2007
Last verified: July 2007
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 21, 2007
Last Updated: July 25, 2007
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Hemorrhage
Hypocalcemia
Vocal Cord Paralysis
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

ClinicalTrials.gov processed this record on May 23, 2013