Plain English Summary
Background and study aims
Providing antithrombotic medication (drugs that reduce the change of blood clots) during surgery could help prevent blood clots and pulmonary embolism (blocking of a bloog vessel in the lung), however this increases the risk of bleeding after surgery. This topic has not been adequately investigated in thyroid surgery. In thyroid surgery, even a small bleeding may result in airway compression and death by asphyxia (a lack of oxygen). The aim of this study is to establish whether providing antithrombotic drugs during surgery can negatively affect the early outcome of patients undergoing total thyroidectomy, with particular reference to the incidence of bleeding and duration of post-operative hospital stay. Therefore this study aims to clarify if antithrombotic drugs administered in order to prevent thromboembolic events are safe and effective in thyroid surgery.
Who can participate?
Adults aged 18 and older who are having a thyroid surgery.
What does the study involve?
Participants underwent thyroidectomy and antithrombotic drugs according with standard surgical criteria and international guidelines for antithrombotic prophylaxis. All patients are subject to a close monitoring in the first 12 hours after surgery and, after discharge, are re-evaluated within 1 week in order to assess the wound and, if appropriate, remove suture. The data from the surgeries are reviewed to assess the impact of the antithrombotic drugs.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.
Where is the study run from?
Policlinico Universitario "Duilio Casula" (Italy)
When is the study starting and how long is it expected to run for?
November 2017 to January 2018
Who is funding the study?
University of Cagliari (Italy)
Who is the main contact?
Dr Enrico Erdas (Scientific)
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11/1968
Study information
Scientific title
Does antithrombotic prophylaxis worsen early outcome of total thyroidectomy? A retrospective cohort study
Acronym
Study hypothesis
It is expected that the incidence of post-operative bleeding and the length of hospital stay after total thyroidectomy would be higher when antithrombotic prophylaxis was administered.
Ethics approval
Institutional Ethical Committee University Hospital of Monserrato, University of Cagliari, 20/11/2017 ref: PROT. PG/2017/8430
Study design
Retrospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please use the contact below to request a patient information sheet erdasenrico@libero.it
Condition
factors influencing outcome of thyroid surgery
Intervention
Participants have antithrombotic prophylaxis with low-molecular-weight heparin (a subcutaneous prophylactic dose (i.e., 0.3 ml) of nadroparin calcium administered the day before their operation and continued for at least 10 days. Participants undergo their thyroid surgery.
After the operation all patients are subject to a close monitoring in the first 12 hours after surgery in order to detect early signs of cervical haematoma, respiratory distress or hypocalcaemia. Drains are removed when the daily amount of fluid collection falls below 20 ml in each reservoir. Parathyroid hormone (PTH) and serum calcium levels are measured on the first and second postoperative day, while further controls are performed only if required (PTH at very low level, clinical signs of hypocalcaemia regardless of serum calcium levels). Post-operative oral calcium and vitamin D supplements are administered in all symptomatic patients with hypocalcemia. After discharge, all patients are re-evaluated within 1 week in order to assess the wound and, if appropriate, remove intradermal suture. All patients underwent telephone follow-up once a week for at least one month.
Researchers review the data about surgical outcomes to investigate the usage of the antithrombotic medication.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Incidence of severe postoperative cervical hematoma is measured using the the need for surgical revision
2. Length of postoperative hospital stay is measured using patient records at discharge
Secondary outcome measures
Incidence of thromboembolic events is measured using the diagnosis of deep vein thrombosis and/or pulmonary embolism.
Overall trial start date
10/11/2017
Overall trial end date
15/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients submitted to total thyroidectomy for whom antithrombotic prophylaxis would be indicated.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
526 patients
Total final enrolment
526
Participant exclusion criteria
1. Aged below 18 years
2. Anticoagulant or antiplatelet therapy
3. Recurrent goitre and operations other than total thyroidectomy (hemithyroidectomy, thyroidectomy with central or lateral neck dissection).
Recruitment start date
01/02/2013
Recruitment end date
31/10/2017
Locations
Countries of recruitment
Italy
Trial participating centre
Policlinico Universitario "Duilio Casula"
09042
Italy
Funders
Funder type
University/education
Funder name
University of Cagliari
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study has been completed and will be sent to an international journal by 15/02/2017.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Enrico Erdas at erdasenrico@libero.it.
Intention to publish date
15/02/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31074394 (added 13/05/2019)