Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Poitiers University Hospital

Status and phase: Unknown; Phase 3

Conditions: Recurrent Paralysis of Vocal Cords

Treatments: Other: Placebo; Drug: Corticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT03553342

THYRCOR

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

156 participants in 2 patient groups, including a placebo group

Corticoids

Experimental group

Treatment:

Drug: Corticoids

Placebo

Placebo Comparator group

Treatment:

Other: Placebo