Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Recurrent Paralysis of Vocal Cords Clinical Trial

Official title:

Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553342
• Other study ID #: THYRCOR
• Status: Recruiting
• Phase: Phase 3
• Start date: September 11, 2018
• Est. completion date: January 11, 2022

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Xavier DUFOUR, Pr
• Phone: 0549444328
• Email: xavier.dufour[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: January 11, 2022
• Est. primary completion date: September 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Paralysis
• Recurrent Paralysis of Vocal Cords
• Vocal Cord Paralysis

Intervention

Drug:
• Corticoids
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.

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

Locations

Country	Name	City	State
France	Chu Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seven days