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

This study has been completed.

First Received on July 21, 2007. Last Updated on July 25, 2007 History of Changes

Sponsor:	Soonchunhyang University Hospital
Information provided by:	Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:	NCT00506103

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:

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.

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 February 13, 2012