GoiterNCT01812395
Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
A study testing Thyroidectomy using harmonic focus (r) and Conventional thyroidectomy in people with Goiter, run by S.B. Konya Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Goiter
- What is being tested?
- Thyroidectomy using harmonic focus (r) and Conventional thyroidectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having thyroidectomy
Who cannot join
- Previous neck surgery
- Thyroid cancers
- History of superior or inferior laryngeal nerve paralysis
- History of neck irradiation
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Education and Research Hospital
Meram, Konya, 42040
Kemal Arslan, M.D., +903322210000 ext. 3209, arslanka74@hotmail.com
Osman Doğru, M.D.
About this study
Official title: Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.
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.
Read the 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.
- Conditions
- Goiter
- Being tested
- Thyroidectomy using harmonic focus (r), Conventional thyroidectomy
- Keywords
- thyroidectomy, ultrasonic dissector, harmonic focus device, superior laryngeal nerve
- Medical subject headings
- Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroidectomy using harmonic focus (r)Device
Also called Ethicon(r) Harmonic Focus(r) Curved Shears
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Conventional thyroidectomyProcedure or surgery
Vessels are ligated with sutures then cut using classic scalpel or scissors.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Dissector Thyroidectomy | Active comparator | Thyroidectomy using harmonic focus (r) device Receives: Device: Thyroidectomy using harmonic focus (r) |
| Classic thyroidectomy | Active comparator | Patients having conventional thyroidectomy Receives: Procedure: Conventional thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Assessment of other complications
Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.B. Konya Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman DOĞRU, M.D., Study director, Konya Education and Research Hospital General Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812395
- Sponsor's protocol ID
- KEAH07031301
- Other IDs
- U1111-1140-3809
- Status last verified
- Mar 2014
- First submitted
- 8 Mar 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21529721Bove 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.
PubMed 21683011Siperstein 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.
PubMed 11822946Yildirim 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.
PubMed 18324377Prgomet 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.
PubMed 19308436Sartori 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.
PubMed 18648850Voutilainen 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.
PubMed 10714624Morton 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.
PubMed 17014444Ozlugedik 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.
PubMed 17022029
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.
- ClinicalTrials.gov ID
- NCT01812395
- Acronym / sponsor ID
- KEAH07031301
- Conditions
- Goiter
- Keywords
- thyroidectomy, ultrasonic dissector, harmonic focus device, superior laryngeal nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- S.B. Konya Education and Research HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Dissector Thyroidectomy | Active comparator | Device: Thyroidectomy using harmonic focus (r)Thyroidectomy using harmonic focus (r) device |
| Classic thyroidectomy | Active comparator | Procedure: Conventional thyroidectomyPatients having conventional thyroidectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having thyroidectomy
Key exclusion criteria (5 listed)
- Previous neck surgery
- Thyroid cancers
- History of superior or inferior laryngeal nerve paralysis
- History of neck irradiation
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroidectomy using harmonic focus (r)Also: Ethicon(r) Harmonic Focus(r) Curved ShearsHarmonic focus(r) device is used to seal and cut the vessels during thyroidectomy. | Device | Ultrasonic Dissector Thyroidectomy |
| Conventional thyroidectomyVessels are ligated with sutures then cut using classic scalpel or scissors. | Procedure or surgery | Classic thyroidectomy |
Primary outcome
Assessment of superior laryngeal nerve function
Time frame: 6 months
Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
2 secondary outcomes
Assessment of inferior laryngeal nerve function
Time frame: 6 months
Assessment of other complications
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Background: PubMed 21529721Pardal-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.
- Background: PubMed 21683011Bove 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.
- Background: PubMed 11822946Siperstein 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.
- Background: PubMed 18324377Yildirim 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.
- Background: PubMed 19308436Prgomet 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.
- Background: PubMed 18648850Sartori 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.
- Background: PubMed 10714624Voutilainen 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.
- Background: PubMed 17014444Morton 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.
- Background: PubMed 17022029Ozlugedik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman DOĞRU, M.D. study director
Konya Education and Research Hospital General Surgery Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroidectomy using harmonic focus (r) and Conventional thyroidectomy in people with Goiter, run by S.B. Konya Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osman DOĞRU, M.D. (+903323236709 ext. 2018, konya422003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of superior laryngeal nerve function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01812395, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.