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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.

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 Summary: 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.
Sponsor: S.B. Konya Education and Research Hospital

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: S.B. Konya Education and Research Hospital

Dates:
Date Received: March 8, 2013
Date Started: March 2013
Date Completion: April 2014
Last Updated: March 21, 2014
Last Verified: March 2014