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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.
Study NCT00506103   Information provided by Soonchunhyang University Hospital
First Received: July 21, 2007   Last Updated: July 25, 2007   History of Changes

July 21, 2007
July 25, 2007
October 2006
 
 
 
Complete list of historical versions of study NCT00506103 on ClinicalTrials.gov Archive Site
 
 
 
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
 

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.

 
 
Observational
Natural History, Longitudinal, Defined Population, Prospective Study
  • Hemorrhage
  • Hypocalcemia
  • Vocal Cord Palsy
 
 
Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
June 2007
 

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00506103
 
SCHHN
Soonchunhyang University Hospital
 
Principal Investigator: Yoon Woo Koh, MD Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
Soonchunhyang University Hospital
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP