NCT01690806

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
Last Updated

September 26, 2012

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

September 19, 2012

Last Update Submit

September 25, 2012

Conditions

Benign Neoplasm of Thyroid GlandMalignant Neoplasm of Thyroid

Study Arms (2)

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

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing thyroid surgery for benign and malignant thyroidal disease

You may qualify if:

  • patients undergoing thyroid surgery

You may not qualify if:

  • ASA physical class III or IV
  • age \> 75 years
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria

L’Aquila, AQ, 67100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 23681030DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Emanuela M CECILIA, M.D.

    Università degli Studi dell'Aquila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 24, 2012

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

September 26, 2012

Record last verified: 2011-08

Locations

IT(1)