Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis (PECV)
Primary Purpose
Thyroidectomy, Paralysis of Vocal Cords
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pre and postoperative ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroidectomy focused on measuring Thyroidectomy, Paralysis of Vocal Cords, Ultrasound
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
Sites / Locations
- Lille Catholic Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre and postoperative ultrasound
Arm Description
An ultrasound is performed in preoperative and in postoperative.
Outcomes
Primary Outcome Measures
Diagnostic performance comparison between ultrasound and nasofibroscopy
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
Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables
Link between the good visualization of the vocal cords by preoperative ultrasound and postoperative ultrasound.
Time for performing ultrasound
Full Information
NCT ID
NCT03727217
First Posted
October 31, 2018
Last Updated
February 2, 2021
Sponsor
Lille Catholic University
Collaborators
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03727217
Brief Title
Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis
Acronym
PECV
Official Title
Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
August 24, 2020 (Actual)
Study Completion Date
August 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
Collaborators
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Paralysis of Vocal Cords
Keywords
Thyroidectomy, Paralysis of Vocal Cords, Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre and postoperative ultrasound
Arm Type
Experimental
Arm Description
An ultrasound is performed in preoperative and in postoperative.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pre and postoperative ultrasound
Intervention Description
An ultrasound is performed in preoperative and in postoperative
Primary Outcome Measure Information:
Title
Diagnostic performance comparison between ultrasound and nasofibroscopy
Description
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.
Time Frame
one hour after surgery
Secondary Outcome Measure Information:
Title
Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables
Description
Link between the good visualization of the vocal cords by preoperative ultrasound and postoperative ultrasound.
Time Frame
before surgery (same day), one hour after surgery
Title
Time for performing ultrasound
Time Frame
one hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Texier, Dr
Organizational Affiliation
Lille Catholic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lille Catholic Hospitals
City
Lomme
State/Province
Nord
ZIP/Postal Code
59462
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis
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