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

NCT00506103 | Completed DMC

• 1 other identifier: SCHHN
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Hypocalcemia; Vocal Cord Palsy

Keywords

Thyroidectomy; Central neck dissection; Harmonic scalpel; Perioperative complications

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine

Bucheon-si, South Korea

Location

Related Publications (1)

• 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. doi: 10.1016/j.surg.2004.09.011.

  PMID: 15746789 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Hypocalcemia; Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and 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

Study Officials

• Yoon Woo Koh, MD

  Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2007
• First Posted: July 25, 2007
• Study Start: October 1, 2006
• Study Completion: June 1, 2007
• Last Updated: July 26, 2007

Record last verified: 2007-07

Locations

KR (1)