Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Phase 3

• Conditions: Recurrent Paralysis of Vocal Cords
• Interventions: Drug: Corticoids; Other: Placebo

• Registration Number: NCT03553342
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Study Start: 2018-09-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29
• Primary Completion: 2021-09-11
• Study Completion: 2022-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticoids	Corticoids	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy	Seven days	evaluated by naso fibroscope inspection

Trial Locations

Locations (1)

Chu Poitiers; 🇫🇷 Poitiers, France