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

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ClinicalTrials.gov Identifier: NCT02855866
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Thyroidectomy Post-operative Swallowing Disorders Procedure: thyroidectomy Other: cryotherapy Drug: cortisone aerosol Drug: Dexamethasone acetate Drug: paracetamol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
Actual Study Start Date : September 3, 2013
Actual Primary Completion Date : February 20, 2015
Actual Study Completion Date : February 20, 2015

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Arm Intervention/treatment
Experimental: cryotherapy Procedure: thyroidectomy
Other: cryotherapy
Drug: Dexamethasone acetate
Drug: paracetamol
Active Comparator: Cortisone aerosol Procedure: thyroidectomy
Drug: cortisone aerosol
Drug: Dexamethasone acetate
Drug: paracetamol
Placebo Comparator: Management Procedure: thyroidectomy
Drug: Dexamethasone acetate
Drug: paracetamol



Primary Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855866


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02855866     History of Changes
Other Study ID Numbers: OSMAK POUSSIER 2013
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Disease
Deglutition Disorders
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Dexamethasone
Cortisone
Dexamethasone acetate
Acetaminophen
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antipyretics
Protease Inhibitors
Enzyme Inhibitors