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

Thyroidectomy Clinical Trial

— DEGLUTHYR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855866
• Other study ID #: OSMAK POUSSIER 2013
• Status: Completed
• Phase: N/A
• Start date: September 3, 2013
• Est. completion date: February 20, 2015

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 20, 2015
• Est. primary completion date: February 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease
• Post-operative Swallowing Disorders
• Thyroidectomy

Intervention

Procedure:
• thyroidectomy

Other:
• cryotherapy

Drug:
• cortisone aerosol

• Dexamethasone acetate

• paracetamol

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)