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

NCT ID: NCT01812395

Last Updated: 2014-03-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Goiter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasonic Dissector Thyroidectomy

Thyroidectomy using harmonic focus (r) device

Group Type ACTIVE_COMPARATOR

Thyroidectomy using harmonic focus (r)

Intervention Type DEVICE

Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.

Classic thyroidectomy

Patients having conventional thyroidectomy

Group Type ACTIVE_COMPARATOR

Conventional thyroidectomy

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Conventional thyroidectomy

Vessels are ligated with sutures then cut using classic scalpel or scissors.

Intervention Type PROCEDURE

Other Intervention Names

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Ethicon(r) Harmonic Focus(r) Curved Shears

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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S.B. Konya Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Osman DOĞRU, M.D.

Role: CONTACT

+903323236709 ext. 2018

Facility Contacts

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Kemal Arslan, M.D.

Role: primary

+903322210000 ext. 3209

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.

Reference Type BACKGROUND
PMID: 21529721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21683011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11822946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18324377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19308436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18648850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10714624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17014444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17022029 (View on PubMed)

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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