Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery

NCT00661024 | Completed DMC

• 1 other identifier: BBN/501/ZKL/L
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Surgery

Keywords

thyroid surgery; recurrent laryngeal nerves visualization; intraoperative neuromonitoring; predictive values

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• the IONM-added value to RLN identification

  intraopreratively

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

RLN visualization alone

Procedure: intraoperative RLN visualization

2

EXPERIMENTAL

IONM of the RLN

Procedure: intraoperative neuromonitoring of the RLN

Interventions

intraoperative RLN visualization PROCEDURE

intraoperative RLN visualization

Also known as: V-G

1

intraoperative neuromonitoring of the RLN PROCEDURE

IONM

Also known as: IONM-G

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• thyroid pathology qualified for first-time bilateral neck surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Department of Endocrine Surgery, Jagiellonian University College of Medicine

Krakow, 37 Pradnicka Street, 31-202, Poland

Location

Related Publications (6)

• 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.

  PMID: 18305996 BACKGROUND

• 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. doi: 10.1016/j.surg.2005.08.027.

  PMID: 16360407 BACKGROUND

• 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. doi: 10.1007/s00268-005-0351-z.

  PMID: 16773263 BACKGROUND

• 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.

  PMID: 17006834 BACKGROUND

• 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. doi: 10.1007/s00423-003-0444-9. Epub 2004 Jan 13.

  PMID: 14722777 BACKGROUND

• Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.

  PMID: 19177420 DERIVED

Study Officials

• Marcin Barczynski, MD, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

• Stanislaw Cichon, Prof, MD

  Jagiellonian University

  STUDY CHAIR

• Aleksander Konturek, MD, PhD

  Jagiellonian University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: January 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: April 1, 2008
• Last Updated: April 18, 2008

Record last verified: 2008-04

Locations

PL (1)