Back to resultsEfficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
Primary Purpose
Recurrent Paralysis of Vocal Cords
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Corticoids
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Paralysis of Vocal Cords
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
- Patients over eighteen years old
- Free subject, whitout tutorship or curatorship or subordination
- Informed consent and signed by the patient after clear and fair information about the study.
Exclusion Criteria:
- Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
- Patients with preoperative recurrent paralysis
- Patients with hypersensitivity to prednisolone or any of the excipients.
- Patients with contraindication to use Solupred
- Patients with anti-inflammatory of acetylsalicylic acid
- Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
Sites / Locations
- Chu PoitiersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Corticoids
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
evaluated by naso fibroscope inspection
Secondary Outcome Measures
Full Information
NCT ID
NCT03553342
First Posted
May 23, 2018
Last Updated
January 28, 2021
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03553342
Brief Title
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
Official Title
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
September 11, 2021 (Anticipated)
Study Completion Date
January 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.
The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Paralysis of Vocal Cords
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corticoids
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Corticoids
Intervention Description
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo for seven days.
Primary Outcome Measure Information:
Title
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
Description
evaluated by naso fibroscope inspection
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
Patients over eighteen years old
Free subject, whitout tutorship or curatorship or subordination
Informed consent and signed by the patient after clear and fair information about the study.
Exclusion Criteria:
Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
Patients with preoperative recurrent paralysis
Patients with hypersensitivity to prednisolone or any of the excipients.
Patients with contraindication to use Solupred
Patients with anti-inflammatory of acetylsalicylic acid
Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier DUFOUR, Pr
Phone
0549444328
Ext
+33
Email
xavier.dufour@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique DE MONTAUDRY, ARC
Phone
05.49.44.45.12
Email
veronique.martin-de-montaudry@chu-poitiers.fr
Facility Information:
Facility Name
Chu Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier DUFOUR, DR
Phone
05.49.44.60.38
Email
xavier.dufour@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Florent CARSUZAA
Email
florent.carsuzaa@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
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