benign goiter E04
Conditions
Interventions
Group 1: continuous intraoperative neuromonitoring C-IONM
Group 2: intermittent intraoperative neuromonitoring I-IONM
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients undergoing total thyroidectomy, or hemithyroidectomy for potentially benign goiter, life expectancy = 12 months, informed consent
Exclusion criteria
Exclusion criteria: proven malignancy, preoperative recurrent laryngeal nerve palsy, previous thyroid surgery, previous parathyroid surgery, previous neck dissection, neurophysiological deficiencies, severe psychiatric or neurologic disease, participation in another intervention trial with interference of intervention and outcome, inability to follow instructions given by the investigator (e.g. insufficient command of language)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of transient postoperative recurrent laryngeal nerve palsy: proportion of nerves with RLN palsy as assessed on the first (or second) postoperative day, based on the number of nerves at risk (NAR) as denominator. Depending on whether a uni- or bilateral surgery is performed, one or two nerves per patient are at risk. RLN palsy is determined by laryngoscopy by a blinded head and neck (HN) specialist. | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion with transient resp. permanent RLN palsy both per NAR and per patient (if the nerve function recovers within 6 months after surgery RLN palsy is defined as transient, otherwise it is defined as permanent); proportion of two-stage resections, operating time, IONM failures, histopathological result | — |
Countries
Germany
Contacts
Public ContactElisabeth Maurer
Philipps-Universität Marburg
Outcome results
None listed