Condition category
Surgery
Date applied
23/01/2018
Date assigned
05/02/2018
Last edited
05/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Enrico Erdas

ORCID ID

Contact details

Policlinico Universitario “Duilio Casula”
SS554
Cagliari
09124
Italy

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

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

Sponsor information

Organisation

University of Cagliari

Sponsor details

Via Università
40
Cagliari
09124
Italy

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes