Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2014
Date assigned
18/02/2014
Last edited
18/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
thomas.lesser@wkg.srh.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Lesser

ORCID ID

Contact details

Strasse des Friedens 122
Gera
07548
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Postoperative hypoparathyroidism (disorder of parathyroid function)

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/01/2014

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/01/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Strasse des Friedens 122
Gera
07548
Germany

Sponsor information

Organisation

SRH Wald-Klinikum Gera (Germany)

Sponsor details

Strasse des Friedens 122
Gera
D-07548
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.waldklinikumgera.de/

Funders

Funder type

Hospital/treatment centre

Funder name

SRH Foundation (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes