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Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01163045
Enrollment
250
Registered
2010-07-15
Start date
2008-01-31
Completion date
2010-01-31
Last updated
2010-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

Keywords

neurostimulation, intraoperative neuromonitoring, recurrent laryngeal nerve, palsy of recurrent laryngeal nerve, RCT

Brief summary

The purpose of this study is to evaluate if intraoperative neuromonitoring associated to neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy respect to neurostimulation alone.

Detailed description

Anatomic and functional preservation of the recurrent laryngeal nerve is a key element of thyroid surgery. Surgical exposure and visual identification of the nerve during thyroid surgery has been shown to provide the best rates of normal postoperative vocal fold function. Nevertheless, identification of the nerve sometimes can be difficult in patients who are heavily scarred or who have undergone previous surgery. Moreover, an anatomical intact nerve does not always correlate with normal vocal fold function. So it is mandatory to identify the nerve and to establish its function. Two techniques are described to facilitate identification of the nerve and to test its function. One is the neurostimulation with laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of RLN or vagal nerve with an electric stimulator probe. More recently some authors have suggested a continuous intraoperative neuromonitoring which provide audio and visual feed back when the nerve is electrically or mechanically stimulated during thyroidectomy. However controversy remains as to whether intraoperative neuromonitoring confers any significant benefit in injury prevention of recurrent laryngeal nerve.

Interventions

PROCEDUREthyroidectomy

total thyroidectomy and lobectomy

Sponsors

University of Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes

Inclusion criteria

* Mono or bilateral thyroid surgery

Exclusion criteria

* Previous thyroid and parathyroid surgery * Thyroidectomy with mono or bilateral neck dissection * Extended thyroidectomy for locally advanced thyroid carcinoma * Retrosternal goitre * Minimally invasive thyroid surgery * Preoperative palsy

Design outcomes

Primary

MeasureTime frame
recurrent laryngeal nerve paralysis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026