Does antithrombotic prophylaxis increase the incidence of post-operative bleeding and duration of post-operative hospital stay after thyroidectomy? A retrospective study
| ISRCTN | ISRCTN12029395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12029395 |
| Secondary identifying numbers | 11/1968 |
- Submission date
- 23/01/2018
- Registration date
- 05/02/2018
- Last edited
- 13/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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)
Contact information
Scientific
Policlinico Universitario “Duilio Casula”
SS554
Cagliari
09124
Italy
Study information
| Study design | Retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use the contact below to request a patient information sheet erdasenrico@libero.it |
| Scientific title | Does antithrombotic prophylaxis worsen early outcome of total thyroidectomy? A retrospective cohort study |
| Study objectives | 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(s) | Institutional Ethical Committee University Hospital of Monserrato, University of Cagliari, 20/11/2017 ref: PROT. PG/2017/8430 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/11/2017 |
| Completion date | 15/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 526 patients |
| Total final enrolment | 526 |
| Key inclusion criteria | All patients submitted to total thyroidectomy for whom antithrombotic prophylaxis would be indicated. |
| Key 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). |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 31/10/2017 |
Locations
Countries of recruitment
- Italy
Study participating centre
Italy
Sponsor information
University/education
Via Università, 40
Cagliari
09124
Italy
"ROR" |
https://ror.org/003109y17 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 15/02/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study has been completed and will be sent to an international journal by 15/02/2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Enrico Erdas at erdasenrico@libero.it. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/04/2019 | 13/05/2019 | Yes | No |
Editorial Notes
13/05/2019: Publication reference and total final enrolment added.
