Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

NCT ID: NCT03553342

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2022-01-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Paralysis of Vocal Cords

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Corticoids

Group Type EXPERIMENTAL

Corticoids

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients will receive placebo for seven days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Corticoids

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

Intervention Type DRUG

Placebo

Patients will receive placebo for seven days.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xavier DUFOUR, Pr

Role: CONTACT

0549444328 ext. +33

Véronique DE MONTAUDRY, ARC

Role: CONTACT

05.49.44.45.12

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xavier DUFOUR, DR

Role: primary

05.49.44.60.38

Florent CARSUZAA

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Carvajal-Alegria E, Girault N, Donatini G, Frasca D, Tonnerre D, Cosset T, Rulliere A, Lebreton JP, Dufour X, Carsuzaa F. Oral Corticosteroids in Vocal Fold Paralysis After Thyroid Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Sep 1;151(9):874-880. doi: 10.1001/jamaoto.2025.2169.

Reference Type DERIVED
PMID: 40773211 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

THYRCOR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

High Dose Steroids for Dysphagia
NCT03256149 WITHDRAWN NA