Benign Neoplasm of Thyroid GlandNCT01690806
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy
An observational study of Benign Neoplasm of Thyroid Gland and Malignant Neoplasm of Thyroid, run by Università degli Studi dell'Aquila at 1 site in Italy.
Trial summary
Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Benign Neoplasm of Thyroid Gland, Malignant Neoplasm of Thyroid
- Type of treatment
- Injection or infusion
- How many people
- 328 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Mar 2012
- Phase
- Observational
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing thyroid surgery for benign and malignant thyroidal disease
Who may be able to join
- patients undergoing thyroid surgery
Who cannot join
- ASA physical class III or IV
- age > 75 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria
L’Aquila, AQ, 67100
About this study
Official title: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp \& Dohme) intravenously 90 min before skin incision | |
| placebo | Patients who receive saline placebo intravenously 90 min before skin incision |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Neoplasm of Thyroid GlandStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CECILIA Emanuela Marina, Università degli Studi dell'Aquila
- Investigators
- Emanuela M CECILIA, M.D., Principal investigator, Università degli Studi dell'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690806
- Sponsor's protocol ID
- OTO: OTO12-0447R
- Status last verified
- Aug 2011
- First submitted
- 19 Sep 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Lancione L, Amicucci G. Dexamethasone for the prevention of recurrent laryngeal nerve palsy and other complications after thyroid surgery: a randomized double-blind placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 May;139(5):471-8. doi: 10.1001/jamaoto.2013.2821.
PubMed 23681030
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01690806
- Acronym / sponsor ID
- OTO: OTO12-0447R
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Università degli Studi dell'AquilaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Sep 2012 (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.
Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | – | –Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp \& Dohme) intravenously 90 min before skin incision |
| placebo | – | –Patients who receive saline placebo intravenously 90 min before skin incision |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing thyroid surgery for benign and malignant thyroidal disease
Key inclusion criteria (1 listed)
- patients undergoing thyroid surgery
Key exclusion criteria (3 listed)
- ASA physical class III or IV
- age > 75 years
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 26 Sep 2012.
- Derived from this study: PubMed 23681030Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Lancione L, Amicucci G. Dexamethasone for the prevention of recurrent laryngeal nerve palsy and other complications after thyroid surgery: a randomized double-blind placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 May;139(5):471-8. doi: 10.1001/jamaoto.2013.2821.
Related trials for Benign Neoplasm of Thyroid Gland
Recruiting
Radiofrequency Ablation Study in LatinX Patients
Thyroid Nodule
Recruiting
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
Thyroid Nodule (Diagnosis)
Active, not recruiting
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
Thyroid Nodule, Thyroid Goiter
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Radiofrequency Ablation for Management of Benign/Indeterminate Thyroid Nodules and Low Risk Papillary Thyroid Cancers
Low Risk, Papillary Thyroid Cancer
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.
Emanuela M CECILIA, M.D. principal investigator
Università degli Studi dell'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Neoplasm of Thyroid Gland and Malignant Neoplasm of Thyroid, run by Università degli Studi dell'Aquila at 1 site in Italy.
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 1 inclusion and 3 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 26 Sep 2012. 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 Italy. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690806, which also lists 1 linked publication.
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 26 Sep 2012.