An interventional study of Thyroidectomy using harmonic focus (r) and Conventional thyroidectomy in Goiter, sponsored by S.B. Konya Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-24.
Sponsored by S.B. Konya Education and Research Hospital · Not applicable, Interventional, and Prevention
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.
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.
66 studies on the registry are indexed under Goiter; 11 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 42 interventional studies indexed under Goiter.
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Exclusion Criteria:
Thyroidectomy using harmonic focus (r) device
Device: Thyroidectomy using harmonic focus (r)
Patients having conventional thyroidectomy
Procedure: Conventional thyroidectomy
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Also known as: Ethicon(r) Harmonic Focus(r) Curved Shears
Vessels are ligated with sutures then cut using classic scalpel or scissors.
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.
Time frame: 6 months
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.
Time frame: 6 months
Assessment of other complications
Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
Time frame: 1 week
Assessment of hemorrhage
Amounts of peroperative and postoperative hemorrhage will be recorded
Time frame: 3 day
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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S.B. Konya Education and Research Hospital