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

Primary Purpose

Thyroidectomy, Post-operative Swallowing Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
thyroidectomy
cryotherapy
cortisone aerosol
Dexamethasone acetate
paracetamol
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

cryotherapy

Cortisone aerosol

Management

Arm Description

Outcomes

Primary Outcome Measures

Swallowing Impairment Score (SIS).

Secondary Outcome Measures

Full Information

First Posted
July 28, 2016
Last Updated
December 20, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02855866
Brief Title
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
Acronym
DEGLUTHYR
Official Title
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2013 (Actual)
Primary Completion Date
February 20, 2015 (Actual)
Study Completion Date
February 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Post-operative Swallowing Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cryotherapy
Arm Type
Experimental
Arm Title
Cortisone aerosol
Arm Type
Active Comparator
Arm Title
Management
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
thyroidectomy
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Type
Drug
Intervention Name(s)
cortisone aerosol
Intervention Type
Drug
Intervention Name(s)
Dexamethasone acetate
Intervention Type
Drug
Intervention Name(s)
paracetamol
Primary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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