Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
NCT ID: NCT01812395
Last Updated: 2014-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2013-03-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Ultrasonic Dissector Thyroidectomy
Thyroidectomy using harmonic focus (r) device
Thyroidectomy using harmonic focus (r)
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Classic thyroidectomy
Patients having conventional thyroidectomy
Conventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.
Interventions
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Thyroidectomy using harmonic focus (r)
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Conventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Thyroid cancers
* History of superior or inferior laryngeal nerve paralysis
* History of neck irradiation
* Pregnant or lactating women
18 Years
65 Years
ALL
No
Sponsors
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S.B. Konya Education and Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Osman DOĞRU, M.D.
Role: STUDY_DIRECTOR
Konya Education and Research Hospital General Surgery Clinic
Locations
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Konya Education and Research Hospital
Meram, Konya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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(R)), a harmonic curved shears (Harmonic Focus), and traditional technique in total thyroidectomy. Am Surg. 2010 Jul;76(7):E94-6. No abstract available.
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. doi: 10.1001/archsurg.137.2.137.
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.
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.
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.
Voutilainen PE, Haglund CH. Ultrasonically activated shears in thyroidectomies: a randomized trial. Ann Surg. 2000 Mar;231(3):322-8. doi: 10.1097/00000658-200003000-00004.
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. doi: 10.1111/j.1749-4486.2006.01266.x.
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. doi: 10.1002/ca.20399.
Other Identifiers
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U1111-1140-3809
Identifier Type: OTHER
Identifier Source: secondary_id
KEAH07031301
Identifier Type: -
Identifier Source: org_study_id
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