Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
Primary Purpose
Goiter
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thyroidectomy using harmonic focus (r)
Conventional thyroidectomy
Sponsored by
About this trial
This is an interventional prevention trial for Goiter focused on measuring thyroidectomy, ultrasonic dissector, harmonic focus device, superior laryngeal nerve
Eligibility Criteria
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
Sites / Locations
- Konya Education and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasonic Dissector Thyroidectomy
Classic thyroidectomy
Arm Description
Thyroidectomy using harmonic focus (r) device
Patients having conventional thyroidectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Assessment of other complications
Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
Full Information
NCT ID
NCT01812395
First Posted
March 8, 2013
Last Updated
March 21, 2014
Sponsor
S.B. Konya Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01812395
Brief Title
Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
Official Title
Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S.B. Konya Education and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goiter
Keywords
thyroidectomy, ultrasonic dissector, harmonic focus device, superior laryngeal nerve
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasonic Dissector Thyroidectomy
Arm Type
Active Comparator
Arm Description
Thyroidectomy using harmonic focus (r) device
Arm Title
Classic thyroidectomy
Arm Type
Active Comparator
Arm Description
Patients having conventional thyroidectomy
Intervention Type
Device
Intervention Name(s)
Thyroidectomy using harmonic focus (r)
Other Intervention Name(s)
Ethicon(r) Harmonic Focus(r) Curved Shears
Intervention Description
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Intervention Type
Procedure
Intervention Name(s)
Conventional thyroidectomy
Intervention Description
Vessels are ligated with sutures then cut using classic scalpel or scissors.
Primary Outcome Measure Information:
Title
Assessment of superior laryngeal nerve function
Description
Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of inferior laryngeal nerve function
Description
Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
Time Frame
6 months
Title
Assessment of other complications
Description
Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Assessment of hemorrhage
Description
Amounts of peroperative and postoperative hemorrhage will be recorded
Time Frame
3 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osman DOĞRU, M.D.
Phone
+903323236709
Ext
2018
Email
konya422003@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman DOĞRU, M.D.
Organizational Affiliation
Konya Education and Research Hospital General Surgery Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Konya Education and Research Hospital
City
Meram
State/Province
Konya
ZIP/Postal Code
42040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kemal Arslan, M.D.
Phone
+903322210000
Ext
3209
Email
arslanka74@hotmail.com
First Name & Middle Initial & Last Name & Degree
Osman Doğru, M.D.
First Name & Middle Initial & Last Name & Degree
Kemal Arslan, M.D.
First Name & Middle Initial & Last Name & Degree
Said S Kökçam, M.D.
First Name & Middle Initial & Last Name & Degree
Hande Köksal, M.D.
First Name & Middle Initial & Last Name & Degree
Ersin Turan, Resident
First Name & Middle Initial & Last Name & Degree
Arif Atay, Resident
First Name & Middle Initial & Last Name & Degree
Gültekin Övet, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21529721
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.
Results Reference
background
PubMed Identifier
21683011
Citation
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.
Results Reference
background
PubMed Identifier
11822946
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. doi: 10.1001/archsurg.137.2.137.
Results Reference
background
PubMed Identifier
18324377
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.
Results Reference
background
PubMed Identifier
19308436
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.
Results Reference
background
PubMed Identifier
18648850
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.
Results Reference
background
PubMed Identifier
10714624
Citation
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.
Results Reference
background
PubMed Identifier
17014444
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. doi: 10.1111/j.1749-4486.2006.01266.x. Erratum In: Clin Otolaryngol. 2007 Feb;32(1):78.
Results Reference
background
PubMed Identifier
17022029
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. doi: 10.1002/ca.20399.
Results Reference
background
Learn more about this trial
Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
We'll reach out to this number within 24 hrs