Does ligation of the thyroid arteries during an operation on the thyroid goiter have an effect on parathyroid function?
| ISRCTN | ISRCTN23666565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23666565 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/02/2014
- Registration date
- 18/02/2014
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
During an operation on the thyroid goitre the arteries for the thyroid gland are usually ligated. The surgeon must see the paratyroid glands. This is the best way to avoid damage to or removal of the parathyroid glands. The ligation of the thyroid arteries and the exposure of the parathyroid glands could have an negative effect on the parathyroid function. The key function of the parathyroid glands is to control the amount of calcium in the blood and within the bones. This study compares two surgery methods and we want to test that the bilateral truncal ligation of the inferior thyroid artery does not alter the parathyroid function.
Who can participate?
Patients who need surgery on the thyroid gland.
What does the study involve?
Patients are randomly allocated to one of two groups. In one group, the inferior thyroid arteries are ligated (this is the method under investigation). In the other group, the inferior thyroid arteries are not ligated (this is the control group). The effect on the parathyroid function is measured. The parathyroid function is measured by blood tests before, during and after the operation. The last test is on day 5 after the operation during the stay in hospital. In addition all patients will receive a clinical examination and will asked about symptoms daily after the operation. The age and how much was resected from the thyroid gland could have an influence on the parathyroid function. This is measured.
What are the possible benefits and risks of participating?
Operations on the thyroid gland present two main risks: damage to the parathyroid glands and injury to a nerve used for the voice. We expect no additional risks.
Where is the study run from?
It is a single center study which takes place in the Departement of Thoracic and Vascular surgery of the SRH Wald-Klinikum Gera, a teachíng hospital of the Friedrich Schiller University of Jena (Germany).
When is the study starting and how long is it expected to run for?
January to December 2014.
Who is funding the study?
This research is being supported by the SRH Foundation, Heidelberg, Germany.
Who is the main contact?
Dr Thomas Günther Lesser
thomas.lesser@wkg.srh.de
Contact information
Scientific
Strasse des Friedens 122
Gera
07548
Germany
Study information
| Study design | Prospective randomized interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect on parathyroid function of bilateral truncal ligation of the inferior thyroid artery during bilateral subtotal thyroidectomy: a randomised clinical trial |
| Study acronym | PTF-ITAL (ParaThyroid Function Inferior Thyroid Artery Ligation) |
| Study objectives | Bilateral truncal ligation of thyroid arteries during subtotal thyroidectomies has no effect on parathyroid function. |
| Ethics approval(s) | Ethics Committee of the Medical Association of Thuringia, 04/07/2012, ref: 35482/2012/77 |
| Health condition(s) or problem(s) studied | Postoperative hypoparathyroidism (disorder of parathyroid function) following thyroidectomy |
| Intervention | Participants are randomized to one of the following two groups: 1. Non-bilateral truncal ligation of the inferior thyroid artery during subtotal thyroidectomy (control group) 2. Bilateral truncal ligation of the inferior thyroid artery during subtotal thyroidectomy (experimental group) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Rate of clinically manifest hypoparathyroidism. Patients are asked about symptoms daily, in the morning and afternoon (i.e., paraesthesia in the face or hands, tingling periorally or in the fingers), and patients are clinically tested for Chvostek's and Trousseau's signs. |
| Secondary outcome measures | Incidence of postoperative asymptomatic hypocalcaemia and hypoparathyroidism, measured one day before the operation, intraoperatively at skin closure, and on postoperative days 2 and 5 during hospital stay. |
| Overall study start date | 01/01/2014 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 patients must be randomized. About 200 patients must be assessed for eligibility. |
| Total final enrolment | 83 |
| Key inclusion criteria | 1. Adult patients (1880 years) with a multinodular non-toxic goitre 2. Normal serum albumin, total calcium and serum parathormone (PTH) 3. Normal vocal cord mobility |
| Key exclusion criteria | 1. Thyroid volume >150 ml 2. Toxic goitre (including Grave's disease) 3. Patients admitted for either unilateral resection or resection of recurrent goitre 4. Parathyroid dysfunction 5. Renal insufficiency 6. Haematopoietic disorders 7. Abnormal calcium metabolism 8. Prior radioiodine therapy |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
07548
Germany
Sponsor information
Hospital/treatment centre
Strasse des Friedens 122
Gera
D-07548
Germany
| Website | http://www.waldklinikumgera.de/ |
|---|---|
"ROR" |
https://ror.org/00q236z92 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | 24/07/2020 | Yes | No |
Editorial Notes
24/07/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
