ThyroidectomyDEGLUTHYRNCT02855866
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
A study testing thyroidectomy, cryotherapy and cortisone aerosol in people with Thyroidectomy and Post-operative Swallowing Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Post-operative Swallowing Disorders
- What is being tested?
- thyroidectomy, cryotherapy and cortisone aerosol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2013to 20 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- thyroidectomy, cryotherapy, cortisone aerosol, Dexamethasone acetate, paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
cryotherapyOther
cortisone aerosolDrug
Dexamethasone acetateDrug
paracetamolDrug
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy | Experimental | Not described Receives: Procedure: thyroidectomy; Other: cryotherapy; Drug: Dexamethasone acetate; Drug: paracetamol |
| Cortisone aerosol | Active comparator | Not described Receives: Procedure: thyroidectomy; Drug: cortisone aerosol; Drug: Dexamethasone acetate; Drug: paracetamol |
| Management | Placebo comparator | Not described Receives: Procedure: thyroidectomy; Drug: Dexamethasone acetate; Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Impairment Score (SIS).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start3 Sep 2013
- Primary completion20 Feb 2015
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855866
- Sponsor's protocol ID
- OSMAK POUSSIER 2013
- Acronym
- DEGLUTHYR
- Status last verified
- Dec 2018
- First submitted
- 28 Jul 2016
- Last updated
- 21 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT02855866
- Acronym / sponsor ID
- DEGLUTHYR / OSMAK POUSSIER 2013
- Conditions
- Thyroidectomy, Post-operative Swallowing Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Sep 2013 (actual)
- Primary completion
- 20 Feb 2015 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroidectomy | Procedure or surgery | 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 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyroidectomy, cryotherapy and cortisone aerosol in people with Thyroidectomy and Post-operative Swallowing Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.