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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Hemorrhage Hypocalcemia Vocal Cord Palsy

Keywords

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Thyroidectomy Central neck dissection Harmonic scalpel Perioperative complications

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Yoon Woo Koh, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bucheon-si, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND

PMID: 15746789 (View on PubMed)

Other Identifiers

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SCHHN

Identifier Type: -

Identifier Source: org_study_id