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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by S.B. Konya Education and Research Hospital
Sponsor:
Information provided by (Responsible Party):
S.B. Konya Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01812395
First received: March 8, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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 Intervention
Goiter
Device: Thyroidectomy using harmonic focus (r)
Procedure: Conventional thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.

Further study details as provided by S.B. Konya Education and Research Hospital:

Primary Outcome Measures:
  • Assessment of superior laryngeal nerve function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.


Secondary Outcome Measures:
  • Assessment of inferior laryngeal nerve function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.

  • Assessment of other complications [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded


Other Outcome Measures:
  • Assessment of hemorrhage [ Time Frame: 3 day ] [ Designated as safety issue: Yes ]
    Amounts of peroperative and postoperative hemorrhage will be recorded


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: March 8, 2013
Last Updated: March 21, 2014
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014