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

Not Applicable

Completed

• Conditions: Thyroidectomy; Post-operative Swallowing Disorders
• Interventions: Procedure: thyroidectomy; Drug: cortisone aerosol; Other: cryotherapy; Drug: Dexamethasone acetate; Drug: paracetamol

• Registration Number: NCT02855866
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-03
• Primary Completion: 2015-02-20
• Study Completion: 2015-02-20
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-04
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cortisone aerosol	cortisone aerosol	-
cryotherapy	Dexamethasone acetate	-
Management	thyroidectomy	-
cryotherapy	thyroidectomy	-
Cortisone aerosol	thyroidectomy	-
cryotherapy	cryotherapy	-
cryotherapy	paracetamol	-
Cortisone aerosol	paracetamol	-
Management	Dexamethasone acetate	-
Management	paracetamol	-
Cortisone aerosol	Dexamethasone acetate	-

Primary Outcome Measures

Name	Time	Method
Swallowing Impairment Score (SIS).	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)

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France