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

July 25, 2007 updated by: Soonchunhyang University Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

  • Principal Investigator: Yoon Woo Koh, MD, Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 21, 2007

First Submitted That Met QC Criteria

July 24, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

July 26, 2007

Last Update Submitted That Met QC Criteria

July 25, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHHN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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