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

Hemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506103
• Other study ID #: SCHHN
• Status: Completed
• Phase: N/A
• First received: July 21, 2007
• Last updated: July 25, 2007
• Start date: October 2006
• Est. completion date: June 2007

Study information

• Verified date: July 2007
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Hemorrhage
• Hypocalcemia
• Vocal Cord Palsy
• Vocal Cord Paralysis

Locations

Country	Name	City	State
Korea, Republic of	Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Cordón C, Fajardo R, Ramírez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41. — View Citation