Skip to main content
OpenTrials
Completed

NCT Number: NCT03727217

Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lille Catholic Hospitals

Lomme, Nord, 59462, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre and postoperative ultrasound

Diagnostic Test

An ultrasound is performed in preoperative and in postoperative

Primary outcomes

  1. Diagnostic performance comparison between ultrasound and nasofibroscopy

    Time frame: 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 outcomes

  1. Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables

    Time frame: before surgery (same day), one hour after surgery

    Link between the good visualization of the vocal cords by preoperative ultrasound and postoperative ultrasound.

  2. Time for performing ultrasound

    Time frame: one hour after surgery

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • University Hospital, Lille

Registry information

Official study title

Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)

Acronym: PECV

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.