Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?

March 21, 2014 updated by: S.B. Konya Education and Research Hospital

Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.

New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are such new devices which is a practical alternative to the usage of scalpel and sutures. UD's cause overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the generated heat UDs might cause nerve injury. The investigators would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We see new advances in the practice of surgery nearly everyday. New techniques and devices became available and even newer ones are under developement. Ultrasonic Dissectors (UDs) which are primarily developed for laparoscopic surgery found widespread use in thyroid surgery. UDs while closing the nearby vessels cause overheating of neighboring tissues in a 1-3 mm. area. Due to the generated heat UDs might cause nerve injury. We would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy where vessels are first sealed with sutures then cut. To this end patients in both conventional and ultrasonic dissector thyroidectomy arms will be checked for superior laryngeal nerve function the day following operation and six months later.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
    • Konya
      • Meram, Konya, Turkey, 42040
        • Recruiting
        • Konya Education and Research Hospital
        • Contact:
        • Principal Investigator:
          • Osman Doğru, M.D.
        • Sub-Investigator:
          • Kemal Arslan, M.D.
        • Sub-Investigator:
          • Said S Kökçam, M.D.
        • Sub-Investigator:
          • Hande Köksal, M.D.
        • Sub-Investigator:
          • Ersin Turan, Resident
        • Sub-Investigator:
          • Arif Atay, Resident
        • Sub-Investigator:
          • Gültekin Övet, M.D.

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having thyroidectomy

Exclusion Criteria:

  • Previous neck surgery
  • Thyroid cancers
  • History of superior or inferior laryngeal nerve paralysis
  • History of neck irradiation
  • Pregnant or lactating women

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasonic Dissector Thyroidectomy
Thyroidectomy using harmonic focus (r) device
Device: Thyroidectomy using harmonic focus (r)
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Other Names:
  • Ethicon(r) Harmonic Focus(r) Curved Shears
Active Comparator: Classic thyroidectomy
Patients having conventional thyroidectomy
Procedure: Conventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of superior laryngeal nerve function
Time Frame: 6 months
Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of inferior laryngeal nerve function
Time Frame: 6 months
Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
6 months
Assessment of other complications
Time Frame: 1 week
Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of hemorrhage
Time Frame: 3 day
Amounts of peroperative and postoperative hemorrhage will be recorded
3 day

Collaborators and Investigators

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

Sponsor

S.B. Konya Education and Research Hospital

Investigators

  • Study Director: Osman DOĞRU, M.D., Konya Education and Research Hospital General Surgery Clinic

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

March 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEAH07031301
  • U1111-1140-3809 (Other Identifier: WHO Universal Trial Number)

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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