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Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

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ClinicalTrials.gov Identifier: NCT03553342
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Recurrent Paralysis of Vocal Cords Drug: Corticoids Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : September 11, 2021
Estimated Study Completion Date : January 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis Steroids

Arm Intervention/treatment
Experimental: Corticoids Drug: Corticoids
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.

Placebo Comparator: Placebo Other: Placebo
Patients will receive placebo for seven days.




Primary Outcome Measures :
  1. Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy [ Time Frame: Seven days ]
    evaluated by naso fibroscope inspection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553342


Contacts
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Contact: Xavier DUFOUR, Pr 0549444328 ext +33 xavier.dufour@chu-poitiers.fr
Contact: Véronique DE MONTAUDRY, ARC 05.49.44.45.12 veronique.martin-de-montaudry@chu-poitiers.fr

Locations
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France
Chu Poitiers Recruiting
Poitiers, France
Contact: Xavier DUFOUR, DR    05.49.44.60.38    xavier.dufour@chu-poitiers.fr   
Contact: Florent CARSUZAA       florent.carsuzaa@gmail.com   
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03553342     History of Changes
Other Study ID Numbers: THYRCOR
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases