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

Goiter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01812395
• Other study ID #: KEAH07031301
• Secondary ID: U1111-1140-3809
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2013
• Last updated: March 21, 2014
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2014
• Source: S.B. Konya Education and Research Hospital
• Contact: Osman DOGRU, M.D.
• Phone: +903323236709
• Email: konya422003[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Goiter

Intervention

Device:
• Thyroidectomy using harmonic focus (r)
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.

Procedure:
• Conventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.

Locations

Country	Name	City	State
Turkey	Konya Education and Research Hospital	Meram	Konya

Sponsors (1)

Lead Sponsor	Collaborator
S.B. Konya Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Bove A, Bongarzoni G, Palone G, Di Renzo R, Di Nicola M, Corradetti L, Corbellini L. Comparative study of an electrothermal bipolar vessel sealing system (LigaSure®), a harmonic curved shears (Harmonic Focus™), and traditional technique in total thyroidectomy. Am Surg. 2010 Jul;76(7):E94-6. — View Citation

Morton RP, Whitfield P, Al-Ali S. Anatomical and surgical considerations of the external branch of the superior laryngeal nerve: a systematic review. Clin Otolaryngol. 2006 Oct;31(5):368-74. Review. Erratum in: Clin Otolaryngol. 2007 Feb;32(1):78. — View Citation

Ozlugedik S, Acar HI, Apaydin N, Tekdemir I, Elhan A, Comert A. Surgical anatomy of the external branch of the superior laryngeal nerve. Clin Anat. 2007 May;20(4):387-91. — View Citation

Pardal-Refoyo JL. [Hemostatic systems in thyroid surgery and complications]. Acta Otorrinolaringol Esp. 2011 Sep-Oct;62(5):339-46. doi: 10.1016/j.otorri.2011.03.004. Epub 2011 May 6. Spanish. — View Citation

Prgomet D, Janjanin S, Bilic M, Prstacic R, Kovac L, Rudes M, Katic V. A prospective observational study of 363 cases operated with three different harmonic scalpels. Eur Arch Otorhinolaryngol. 2009 Dec;266(12):1965-70. doi: 10.1007/s00405-009-0954-3. Epub 2009 Mar 24. — View Citation

Sartori PV, De Fina S, Colombo G, Pugliese F, Romano F, Cesana G, Uggeri F. Ligasure versus Ultracision in thyroid surgery: a prospective randomized study. Langenbecks Arch Surg. 2008 Sep;393(5):655-8. doi: 10.1007/s00423-008-0386-3. Epub 2008 Jul 22. — View Citation

Siperstein AE, Berber E, Morkoyun E. The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery. Arch Surg. 2002 Feb;137(2):137-42. — View Citation

Voutilainen PE, Haglund CH. Ultrasonically activated shears in thyroidectomies: a randomized trial. Ann Surg. 2000 Mar;231(3):322-8. — View Citation

Yildirim O, Umit T, Ebru M, Bulent U, Belma K, Betul B, Mete D, Omer C. Ultrasonic harmonic scalpel in total thyroidectomies. Adv Ther. 2008 Mar;25(3):260-5. doi: 10.1007/s12325-008-0024-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of hemorrhage	Amounts of peroperative and postoperative hemorrhage will be recorded	3 day	Yes
Primary	Assessment of superior laryngeal nerve function	Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.	6 months	Yes
Secondary	Assessment of inferior laryngeal nerve function	Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.	6 months	Yes
Secondary	Assessment of other complications	Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded	1 week	Yes