Clinical trial NCT03727217: Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis
Official title: Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Paralysis of Vocal Cords
Keywords: Thyroidectomy
Paralysis of Vocal Cords
Ultrasound
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2018-11-01
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords, and the consequences can be serious.

In this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

Detailed description: Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords. Indeed, the anatomy of the thyroid and its close location with the recurrent laryngeal nerve (responsible for the vocal cord movement) involves a possible lesion or inflammation of the nerve during the surgical procedure. This complication is common, affecting around 10% of thyroid or parathyroid patients following surgery. This complication can be reversible, with a speech therapy or a specific endoscopic treatment by an otolaryngologist.

Currently, a postoperative screening is performed by nasofibroscopy in the recovery room to directly visualize vocal cord mobility. This examination may be painful or badly tolerated by some patients.

Recent studies have highlighted the performance of ultrasound in this diagnosis. The protocol for these studies included an ultrasound distant of the intervention, while it is known that vocal cord paralysis may have earlier consequences.

In this study, the investigators would like to evaluate diagnostic performances of vocal cords ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

The main limitation of vocal cord ultrasound is mainly related to surgery. Surgery creates anatomical rearrangements, so the secondary objective of this study will be to test whether the preoperative visualization is predictive of a good postoperative visualization.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Scheduled surgery of total or partial thyroidectomy or parathyroidectomy
* Patient been informed and given his/her written consent to participate
* Patient affiliated to a social security scheme

Exclusion Criteria:

- Patient under tutorship or curatorship

Primary outcomes:
measure: Diagnostic performance comparison between ultrasound and nasofibroscopy
timeFrame: one hour after surgery
Secondary outcomes:
measure: Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables
timeFrame: before surgery (same day), one hour after surgery
measure: Time for performing ultrasound
timeFrame: one hour after surgery
Other outcomes:
Locations:
city: Lomme
country: France
facility: Lille Catholic Hospitals
state: Nord
Study officials:
affiliation: Lille Catholic University
name: Claire Texier, Dr
role: PRINCIPAL_INVESTIGATOR
References: