Thyroid Surgery Clinical Trial
Official title:
Randomized Clinical Trial Evaluating Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery
Verified date | April 2008 |
Source | Jagiellonian University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Poland: Ministry of Health |
Study type | Interventional |
Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.
Status | Completed |
Enrollment | 1000 |
Est. completion date | April 2008 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - thyroid pathology qualified for first-time bilateral neck surgery Exclusion Criteria: - previous thyroid or parathyroid surgery, - unilateral thyroid pathology eligible for minimally invasive approach (MIVAT), - mediastinal goiter, - preoperatively diagnosed RLN palsy, - pregnancy or lactation, - age below 18 years, - high-risk patients ASA 4 grade (American Society of Anesthesiology), - and inability to comply with the scheduled follow-up protocol. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Poland | Department of Endocrine Surgery, Jagiellonian University College of Medicine | Krakow | 37 Pradnicka Street |
Lead Sponsor | Collaborator |
---|---|
Jagiellonian University |
Poland,
Barczynski M, Konturek A, Cichon S. [Value of the intraoperative neuromonitoring in surgery for thyroid cancer in identification and prognosis of function of the recurrent laryngeal nerves]. Endokrynol Pol. 2006 Jul-Aug;57(4):343-6. Polish. — View Citation
Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2. Review. — View Citation
Snyder SK, Hendricks JC. Intraoperative neurophysiology testing of the recurrent laryngeal nerve: plaudits and pitfalls. Surgery. 2005 Dec;138(6):1183-91; discussion 1191-2. — View Citation
Thomusch O, Sekulla C, Machens A, Neumann HJ, Timmermann W, Dralle H. Validity of intra-operative neuromonitoring signals in thyroid surgery. Langenbecks Arch Surg. 2004 Nov;389(6):499-503. Epub 2004 Jan 13. — View Citation
Tomoda C, Hirokawa Y, Uruno T, Takamura Y, Ito Y, Miya A, Kobayashi K, Matsuzuka F, Kuma K, Miyauchi A. Sensitivity and specificity of intraoperative recurrent laryngeal nerve stimulation test for predicting vocal cord palsy after thyroid surgery. World J Surg. 2006 Jul;30(7):1230-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the incidence of the recurrent laryngeal nerve injury | on 2nd postoperative day and than at 1, 2, 4, 6 and 12 months postoperatively, if paresis was noted on first examination | Yes | |
Secondary | the IONM-added value to RLN identification | intraopreratively | Yes | |
Secondary | the value of IONM in prediction of postoperative vocal cords function | intraoperative data compared with observation of vocal cords function postoperatively on the 2nd day postop | Yes |
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