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

Completed

• Conditions: Hemorrhage; Hypocalcemia; Vocal Cord Palsy

• Registration Number: NCT00506103
• Lead Sponsor: Soonchunhyang University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study Completion: 2007-06
• Status Verified: 2007-07
• Study First Submitted: 2007-07-21
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-25
• Last Update Submitted: 2007-07-25
• Last Update Posted: 2007-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine; 🇰🇷 Bucheon, Korea, Republic of