Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information



Primary contact

Dr Thomas Lesser


Contact details

Strasse des Friedens 122

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The effect on parathyroid function of bilateral truncal ligation of the inferior thyroid artery during bilateral subtotal thyroidectomy: a randomised clinical trial


PTF-ITAL (ParaThyroid Function – Inferior Thyroid Artery Ligation)

Study hypothesis

Bilateral truncal ligation of thyroid arteries during subtotal thyroidectomies has no effect on parathyroid function.

Ethics approval

Ethics Committee of the Medical Association of Thuringia, 04/07/2012, ref: 35482/2012/77

Study design

Prospective randomized interventional trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Postoperative hypoparathyroidism (disorder of parathyroid function)


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



Not Applicable

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Adult patients (18–80 years) with a multinodular non-toxic goitre
2. Normal serum albumin, total calcium and serum parathormone (PTH)
3. Normal vocal cord mobility

Participant type


Age group




Target number of participants

96 patients must be randomized. About 200 patients must be assessed for eligibility.

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Strasse des Friedens 122

Sponsor information


SRH Wald-Klinikum Gera (Germany)

Sponsor details

Strasse des Friedens 122

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

SRH Foundation (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes