Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03553342

Enrollment

156

Registered

2018-06-12

Start date

2018-09-11

Completion date

2022-01-11

Last updated

2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Paralysis of Vocal Cords

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.

Interventions

DRUGCorticoids

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

OTHERPlacebo

Patients will receive placebo for seven days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactXavier DUFOUR, Pr

xavier.dufour@chu-poitiers.fr0549444328

Backup ContactVéronique DE MONTAUDRY, ARC

veronique.martin-de-montaudry@chu-poitiers.fr05.49.44.45.12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026