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

NCT02855866 | Completed

• 1 other identifier: OSMAK POUSSIER 2013
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Thyroidectomy; Post-operative Swallowing Disorders

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

cryotherapy

EXPERIMENTAL

Procedure: thyroidectomy; Other: cryotherapy; Drug: Dexamethasone acetate; Drug: paracetamol

Cortisone aerosol

ACTIVE COMPARATOR

Procedure: thyroidectomy; Drug: cortisone aerosol; Drug: Dexamethasone acetate; Drug: paracetamol

Management

PLACEBO COMPARATOR

Procedure: thyroidectomy; Drug: Dexamethasone acetate; Drug: paracetamol

Interventions

thyroidectomy PROCEDURE

Cortisone aerosol; Management; cryotherapy

cryotherapy OTHER

cryotherapy

cortisone aerosol DRUG

Cortisone aerosol

Dexamethasone acetate DRUG

Cortisone aerosol; Management; cryotherapy

paracetamol DRUG

Cortisone aerosol; Management; cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

Thyroidectomy; Cryotherapy; dexamethasone acetate; Acetaminophen

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 4, 2016
• Study Start: September 3, 2013
• Primary Completion: February 20, 2015
• Study Completion: February 20, 2015
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

FR (1)