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

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)

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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