Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy (DEGLUTHYR)

December 20, 2018 updated by: Centre Hospitalier Universitaire Dijon
The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne

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 about to undergo total thyroidectomy by cervicotomy
  • Single surgeon: Dr Osmak-Tizon Liliana
  • Patients who have provided written consent to take part in the research
  • Hospitalized in the endocrine surgery unit
  • Whose mental and physical state allows them to participate in the quantification of a symptom using a Visual Analogue Scale(VAS)

Exclusion Criteria:

  • Patients under 18 or adults under guardianship
  • Patients about to undergo unilateral thyroid surgery (thyroid lobectomy)
  • Patient who have had parathyroid surgery
  • History of cervicotomy
  • Intolerance to, contra-indication for or allergy to any of the treatments tested.
  • Pregnant or breast-feeding women
  • Patients without national health insurance cover

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cryotherapy
Drug: paracetamol
Drug: Dexamethasone acetate
Procedure: thyroidectomy
Other: cryotherapy
Active Comparator: Cortisone aerosol
Drug: paracetamol
Drug: Dexamethasone acetate
Procedure: thyroidectomy
Drug: cortisone aerosol
Placebo Comparator: Management
Drug: paracetamol
Drug: Dexamethasone acetate
Procedure: thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Swallowing Impairment Score (SIS).
Time Frame: Evolution of the SIS from baseline (inclusion), to the end of the surgery and every day thereafter until discharge of the patient(up to 3 months)
Evolution of the SIS from baseline (inclusion), to the end of the surgery and every day thereafter until discharge of the patient(up to 3 months)

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 3, 2013

Primary Completion (Actual)

February 20, 2015

Study Completion (Actual)

February 20, 2015

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSMAK POUSSIER 2013

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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