Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
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|ClinicalTrials.gov Identifier: NCT01812395|
Recruitment Status : Unknown
Verified March 2014 by S.B. Konya Education and Research Hospital.
Recruitment status was: Recruiting
First Posted : March 18, 2013
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Goiter||Device: Thyroidectomy using harmonic focus (r) Procedure: Conventional thyroidectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||April 2014|
Active Comparator: Ultrasonic Dissector Thyroidectomy
Thyroidectomy using harmonic focus (r) device
Device: Thyroidectomy using harmonic focus (r)
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
Other Name: Ethicon(r) Harmonic Focus(r) Curved Shears
Active Comparator: Classic thyroidectomy
Patients having conventional thyroidectomy
Procedure: Conventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.
- 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.
- Assessment of inferior laryngeal nerve function [ Time Frame: 6 months ]Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
- Assessment of other complications [ Time Frame: 1 week ]Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded
- Assessment of hemorrhage [ Time Frame: 3 day ]Amounts of peroperative and postoperative hemorrhage will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812395
|Contact: Osman DOĞRU, M.D.||+903323236709 ext firstname.lastname@example.org|
|Konya Education and Research Hospital||Recruiting|
|Meram, Konya, Turkey, 42040|
|Contact: Kemal Arslan, M.D. +903322210000 ext 3209 email@example.com|
|Principal Investigator: Osman Doğru, M.D.|
|Sub-Investigator: Kemal Arslan, M.D.|
|Sub-Investigator: Said S Kökçam, M.D.|
|Sub-Investigator: Hande Köksal, M.D.|
|Sub-Investigator: Ersin Turan, Resident|
|Sub-Investigator: Arif Atay, Resident|
|Sub-Investigator: Gültekin Övet, M.D.|
|Study Director:||Osman DOĞRU, M.D.||Konya Education and Research Hospital General Surgery Clinic|