Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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:
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| Active Comparator: Classic thyroidectomy Patients having conventional thyroidectomy |
Procedure: Conventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.
|
Outcome Measures
Primary Outcome Measures
- Assessment of superior laryngeal nerve function [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
- Assessment of inferior laryngeal nerve function [6 months]
Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
- Assessment of other complications [1 week]
Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
Other Outcome Measures
- Assessment of hemorrhage [3 day]
Amounts of peroperative and postoperative hemorrhage will be recorded
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients having thyroidectomy
Exclusion Criteria:
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Previous neck surgery
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Thyroid cancers
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History of superior or inferior laryngeal nerve paralysis
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History of neck irradiation
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Pregnant or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Konya Education and Research Hospital | Meram | Konya | Turkey | 42040 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- Prgomet D, Janjanin S, Bilić M, Prstacić R, Kovac L, Rudes M, Katić 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.
- 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.
- 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.
- Voutilainen PE, Haglund CH. Ultrasonically activated shears in thyroidectomies: a randomized trial. Ann Surg. 2000 Mar;231(3):322-8.
- 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.
- KEAH07031301
- U1111-1140-3809