Continuous vs. intermittent intraoperative neuromonitoring for reduction of transient recurrent laryngeal nerve palsy in thyroid surgery - a prospective randomized controlled multicenter clinical trial (CITY-Trial)

Not Applicable

Recruiting

Conditions: benign goiter
E04
Other nontoxic goitre

Registration Number: DRKS00033520

Lead Sponsor: Philipps-Universität Marburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2426

Inclusion Criteria

patients undergoing total thyroidectomy, or hemithyroidectomy for potentially benign goiter, life expectancy = 12 months, informed consent

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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