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

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ClinicalTrials.gov Identifier: NCT01812395
Recruitment Status : Unknown
Verified March 2014 by S.B. Konya Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2013
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
S.B. Konya Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Goiter Device: Thyroidectomy using harmonic focus (r) Procedure: Conventional thyroidectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.
Study Start Date : March 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : April 2014

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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Assessment of other complications [ Time Frame: 1 week ]
    Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded


Other Outcome Measures:
  1. Assessment of hemorrhage [ Time Frame: 3 day ]
    Amounts of peroperative and postoperative hemorrhage will be recorded



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812395


Contacts
Contact: Osman DOĞRU, M.D. +903323236709 ext 2018 konya422003@yahoo.com

Locations
Turkey
Konya Education and Research Hospital Recruiting
Meram, Konya, Turkey, 42040
Contact: Kemal Arslan, M.D.    +903322210000 ext 3209    arslanka74@hotmail.com   
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.         
Sponsors and Collaborators
S.B. Konya Education and Research Hospital
Investigators
Study Director: Osman DOĞRU, M.D. Konya Education and Research Hospital General Surgery Clinic

Publications:

Responsible Party: S.B. Konya Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01812395     History of Changes
Other Study ID Numbers: KEAH07031301
U1111-1140-3809 ( Other Identifier: WHO Universal Trial Number )
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014

Keywords provided by S.B. Konya Education and Research Hospital:
thyroidectomy
ultrasonic dissector
harmonic focus device
superior laryngeal nerve