Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis

Not Applicable

Completed

• Conditions: Thyroidectomy; Paralysis of Vocal Cords
• Interventions: Diagnostic Test: Pre and postoperative ultrasound

• Registration Number: NCT03727217
• Lead Sponsor: Lille Catholic University

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.

Study Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Primary Completion: 2020-08-24
• Study Completion: 2020-08-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre and postoperative ultrasound	Pre and postoperative ultrasound	An ultrasound is performed in preoperative and in postoperative.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance comparison between ultrasound and nasofibroscopy	one hour after surgery	Diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the immediate postoperative ultrasound (within one hour after the end of surgery), the gold standard being nasofibroscopy.

Secondary Outcome Measures

Name	Time	Method
Time for performing ultrasound	one hour after surgery
Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables	before surgery (same day), one hour after surgery	Link between the good visualization of the vocal cords by preoperative ultrasound and postoperative ultrasound.

Trial Locations

Locations (1)

Lille Catholic Hospitals; 🇫🇷 Lomme, Nord, France