NCT01812395

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 8, 2013

Last Update Submit

March 21, 2014

Conditions

Goiter

Keywords

thyroidectomyultrasonic dissectorharmonic focus devicesuperior laryngeal nerve

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Assessment of inferior laryngeal nerve function

    6 months

  • Assessment of other complications

    1 week

Other Outcomes (1)

  • Assessment of hemorrhage

    3 day

Study Arms (2)

Ultrasonic Dissector Thyroidectomy

ACTIVE COMPARATOR

Thyroidectomy using harmonic focus (r) device

Device: Thyroidectomy using harmonic focus (r)

Classic thyroidectomy

ACTIVE COMPARATOR

Patients having conventional thyroidectomy

Procedure: Conventional thyroidectomy

Interventions

Thyroidectomy using harmonic focus (r)DEVICE

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

Also known as: Ethicon(r) Harmonic Focus(r) Curved Shears
Ultrasonic Dissector Thyroidectomy
Conventional thyroidectomyPROCEDURE

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

Classic thyroidectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having thyroidectomy

You may not qualify if:

  • Previous neck surgery
  • Thyroid cancers
  • History of superior or inferior laryngeal nerve paralysis
  • History of neck irradiation
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Education and Research Hospital

Meram, Konya, 42040, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • 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.

    PMID: 21529721BACKGROUND

  • 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.

    PMID: 21683011BACKGROUND

  • 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.

    PMID: 11822946BACKGROUND

  • 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.

    PMID: 18324377BACKGROUND

  • 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.

    PMID: 19308436BACKGROUND

  • 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.

    PMID: 18648850BACKGROUND

  • 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.

    PMID: 10714624BACKGROUND

  • 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.

    PMID: 17014444BACKGROUND

  • 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.

    PMID: 17022029BACKGROUND

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Osman DOĞRU, M.D.

    Konya Education and Research Hospital General Surgery Clinic

    STUDY DIRECTOR

Central Study Contacts

Osman DOĞRU, M.D.

CONTACT

+903323236709konya422003@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 18, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

TU(1)