Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
|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
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|