Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

January 28, 2021 updated by: Poitiers University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Patients will receive placebo for seven days.
Experimental: Corticoids
Drug: Corticoids
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2018

Primary Completion (Anticipated)

September 11, 2021

Study Completion (Anticipated)

January 11, 2022

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THYRCOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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