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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Post-operative Swallowing Disorders
Thyroidectomy

Treatments

Drug: paracetamol
Procedure: thyroidectomy
Drug: Dexamethasone acetate
Other: cryotherapy
Drug: cortisone aerosol

Study type

Interventional

Funder types

Other

Identifiers

NCT02855866
OSMAK POUSSIER 2013

Details and patient eligibility

About

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).

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 3 patient groups, including a placebo group

cryotherapy
Experimental group
Treatment:
Drug: Dexamethasone acetate
Other: cryotherapy
Drug: paracetamol
Procedure: thyroidectomy
Cortisone aerosol
Active Comparator group
Treatment:
Drug: Dexamethasone acetate
Drug: cortisone aerosol
Drug: paracetamol
Procedure: thyroidectomy
Management
Placebo Comparator group
Treatment:
Drug: Dexamethasone acetate
Drug: paracetamol
Procedure: thyroidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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