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

Sponsor

Soonchunhyang University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00506103

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hemorrhage Hypocalcemia Vocal Cord Palsy

Study Design

Study Type:

Observational

Observational Model:

Defined Population

Time Perspective:

Prospective

Study Start Date :

Oct 1, 2006

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.