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Completed

NCT Number: NCT02855866

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

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).

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Key information

Conditions

Thyroidectomy Post-operative Swallowing Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroidectomy

Procedure

Cryotherapy

Other

cortisone aerosol

Drug

Dexamethasone acetate

Drug

Paracetamol

Drug

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: DEGLUTHYR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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