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

NCT ID: NCT02855866

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-03

Study Completion Date

2015-02-20

Brief Summary

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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

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Conditions

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Thyroidectomy Post-operative Swallowing Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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cryotherapy

Group Type EXPERIMENTAL

thyroidectomy

Intervention Type PROCEDURE

cryotherapy

Intervention Type OTHER

Dexamethasone acetate

Intervention Type DRUG

paracetamol

Intervention Type DRUG

Cortisone aerosol

Group Type ACTIVE_COMPARATOR

thyroidectomy

Intervention Type PROCEDURE

cortisone aerosol

Intervention Type DRUG

Dexamethasone acetate

Intervention Type DRUG

paracetamol

Intervention Type DRUG

Management

Group Type PLACEBO_COMPARATOR

thyroidectomy

Intervention Type PROCEDURE

Dexamethasone acetate

Intervention Type DRUG

paracetamol

Intervention Type DRUG

Interventions

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thyroidectomy

Intervention Type PROCEDURE

cryotherapy

Intervention Type OTHER

cortisone aerosol

Intervention Type DRUG

Dexamethasone acetate

Intervention Type DRUG

paracetamol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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OSMAK POUSSIER 2013

Identifier Type: -

Identifier Source: org_study_id