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Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.

Primary Purpose

Thyroid,, Goiter,

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Neuromonitoring
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid, focused on measuring External branch of the superior laryngeal nerve,, Recurrent laryngeal nerve,, Intraoperative neuromonitoring,, Thyroid surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume).

Exclusion Criteria:

  • male gender,
  • previous neck surgery,
  • unilateral thyroid pathology eligible for unilateral lobectomy,
  • goiter volume above 100 ml,
  • preoperatively diagnosed RLN palsy,
  • abnormal preoperative voice assessment on GRBAS scale,
  • pregnancy or lactation,
  • age below 18 years,
  • high-risk patients ASA 4 grade (American Society of Anesthesiology),
  • inability to comply with the scheduled follow-up protocol.

Sites / Locations

  • Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Visualization of the EBSLN and RLN

Neuromonitoring of the EBSLN and RLN

Arm Description

Visual inspection of the nerves.

Electrical stimulation and monitoring of the nerves' function.

Outcomes

Primary Outcome Measures

The identification rate of the external branch of the superior laryngeal nerve.

Secondary Outcome Measures

Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.
The changes in postoperative voice performance.
The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.

Full Information

First Posted
July 13, 2011
Last Updated
July 14, 2011
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT01395134
Brief Title
Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
Official Title
Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jagiellonian University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
Detailed Description
Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid,, Goiter,
Keywords
External branch of the superior laryngeal nerve,, Recurrent laryngeal nerve,, Intraoperative neuromonitoring,, Thyroid surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visualization of the EBSLN and RLN
Arm Type
No Intervention
Arm Description
Visual inspection of the nerves.
Arm Title
Neuromonitoring of the EBSLN and RLN
Arm Type
Experimental
Arm Description
Electrical stimulation and monitoring of the nerves' function.
Intervention Type
Device
Intervention Name(s)
Neuromonitoring
Other Intervention Name(s)
IONM
Intervention Description
Electrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles.
Primary Outcome Measure Information:
Title
The identification rate of the external branch of the superior laryngeal nerve.
Time Frame
up to 6 months postoperatively
Secondary Outcome Measure Information:
Title
Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.
Time Frame
up to 6 months postoperatively
Title
The changes in postoperative voice performance.
Description
The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
Time Frame
up to 6 months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume). Exclusion Criteria: male gender, previous neck surgery, unilateral thyroid pathology eligible for unilateral lobectomy, goiter volume above 100 ml, preoperatively diagnosed RLN palsy, abnormal preoperative voice assessment on GRBAS scale, pregnancy or lactation, age below 18 years, high-risk patients ASA 4 grade (American Society of Anesthesiology), inability to comply with the scheduled follow-up protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Barczynski, MD, PhD
Organizational Affiliation
Jagiellonian University, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
City
Krakow
ZIP/Postal Code
31-202
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
1463114
Citation
Cernea CR, Ferraz AR, Furlani J, Monteiro S, Nishio S, Hojaij FC, Dutra Junior A, Marques LA, Pontes PA, Bevilacqua RG. Identification of the external branch of the superior laryngeal nerve during thyroidectomy. Am J Surg. 1992 Dec;164(6):634-9. doi: 10.1016/s0002-9610(05)80723-8.
Results Reference
background
PubMed Identifier
1399571
Citation
Cernea CR, Ferraz AR, Nishio S, Dutra A Jr, Hojaij FC, dos Santos LR. Surgical anatomy of the external branch of the superior laryngeal nerve. Head Neck. 1992 Sep-Oct;14(5):380-3. doi: 10.1002/hed.2880140507.
Results Reference
background
PubMed Identifier
21181860
Citation
Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119.
Results Reference
background
PubMed Identifier
19958945
Citation
Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.
Results Reference
background
PubMed Identifier
11742338
Citation
Bellantone R, Boscherini M, Lombardi CP, Bossola M, Rubino F, De Crea C, Alesina P, Traini E, Cozza T, D'alatri L. Is the identification of the external branch of the superior laryngeal nerve mandatory in thyroid operation? Results of a prospective randomized study. Surgery. 2001 Dec;130(6):1055-9. doi: 10.1067/msy.2001.118375.
Results Reference
background
PubMed Identifier
22402975
Citation
Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.
Results Reference
derived

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Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.

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