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Efficacy 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
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Paralysis of Vocal Cords

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 23, 2018
Last Updated
January 28, 2021
Sponsor
Poitiers University Hospital
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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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