Total versus near-total thyroidectomy in Graves`disease- a multi centered prospective randomized controlled clinical trial to evaluate postoperative transient hypoparathyroidism after definite surgery in Graves`disease

Total versus near-total thyroidectomy in Graves`disease- a multi centered prospective randomized controlled clinical trial to evaluate postoperative transient hypoparathyroidism after definite surgery in Graves`disease - TONIG

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004161

Enrollment

300

Registered

2012-06-04

Start date

2015-09-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E89.2 E05.0

Interventions

Group 1: Near-totoal thyroidectomy (near-tital removal of the thyroid gland leaving bilateral remnants of </= 1g on each side around the lateral thyrohyoid ligament of Berry) Group 2: Total thyroidect

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with Graves` disease indicated for definite surgery according to the national guideline; indications are: intolerance of thermostatic medication, persistent or recurrent hyperthyreosis, thyroid growth, endocrine orbitopathy, contraindications for radio iodine therapy; other inclusion criteria are: no history of previous thyroid- and/ or parathyroid surgery; Normal vocal cord function; Age >/= 18 years; Expectancy of life greater than 12 months; Informed consent

Exclusion criteria

Exclusion criteria: Patients with Graves` disease eligible for conservative treatment; (Suspected) malignancy; impairment of parathyroid function; Neurophysiological deficiencies

Design outcomes

Primary

Measure	Time frame
The incidence of transient hypoparathyroidism is defined as the primary efficacy endpoint. Transient hypoparathyroidism is defined as an inadequate parathyroid function not exceeding six months after surgery. Serum calcium- and parathyroid hormone- (PTH) levels and substitutional medication to achieve normocalcemia are used to assess hypoparathyroidism. No evidenece- or consensus based definition of postoperative hypoparathyroidism based on calcium and PTH cut-off levels exists. Therefore, we defined postoperative hypoparathyroidism as calcium and PTH levels below the normal range. Postoperative hypoparathyroidism is considered to be symptomatic in case of at least one of the following symptoms: carpo-pedal paresthesia, numbness or spams and anxiety. Application type, form and dosage of calcium and vitamin-D substitution therapy to achieve normocalcemia are registered. Postoperative hypoparathyroidism is defined transient, if calcium and vitamin-D substitution therapy to achieve normocalcemia are required for less than six months after surgery. The parameters are recorded before surgery, at the day of discharge, six months and 12 months after surgery.	—

Measure

Time frame

The incidence of transient hypoparathyroidism is defined as the primary efficacy endpoint. Transient hypoparathyroidism is defined as an inadequate parathyroid function not exceeding six months after surgery. Serum calcium- and parathyroid hormone- (PTH) levels and substitutional medication to achieve normocalcemia are used to assess hypoparathyroidism. No evidenece- or consensus based definition of postoperative hypoparathyroidism based on calcium and PTH cut-off levels exists. Therefore, we defined postoperative hypoparathyroidism as calcium and PTH levels below the normal range. Postoperative hypoparathyroidism is considered to be symptomatic in case of at least one of the following symptoms: carpo-pedal paresthesia, numbness or spams and anxiety. Application type, form and dosage of calcium and vitamin-D substitution therapy to achieve normocalcemia are registered. Postoperative hypoparathyroidism is defined transient, if calcium and vitamin-D substitution therapy to achieve normocalcemia are required for less than six months after surgery. The parameters are recorded before surgery, at the day of discharge, six months and 12 months after surgery.

—

Secondary

Measure	Time frame
Secondary outcome measures comprise the incidences of permanent hypoparathyroidism, recurrent Graves’ disease, temporary and permanent recurrent laryngeal nerve palsy and reoperations due to bleeding and the number of inadvertently removed parathyroids as well as changes of endocrine orbitopathies and quality of life. Permanent hypoparythroidism is defined as persisting inadequate parathyroid function exceeding six months after surgery. The incidence of recurrent Graves’ disease is assessed through laboratory thyroid function tests (TSH 6.5 pmol/l, fT4 > 21 pmol/l) and the antibody level of thyroidea receptor anti-body (TRAK > 1.75U/l) six weeks, six months and 12 months after surgery with respect to concomitant substitution or thyreostatic medications to achieve an euthyroid state. Cervical ultrasound follows elevated antibody levels to screen for recurrence. Reoperations are reported as serious adverse events. Incidences of temporary and permanent recurrent laryngeal nerve palsies are assessed through laryngoscopy on the day of discharge and, in case of pathological findings within this examination only, at the six weeks, six months and 12 months after surgery. The number of inadvertently removed parathyroids will be counted from histopathology reports at the day of discharge. In case endocrine orbitopathy can be assumed from medical history and/or clinical examination before and/or 12 months after surgery, an ophthalmologist will check for chracteristics of endocrine orbitopathy . Changes in Quality of life are scored before surgery and 6 weeks thereafter using the validated multipurpose health survey questionnaire SF36.	—

Measure

Time frame

Secondary outcome measures comprise the incidences of permanent hypoparathyroidism, recurrent Graves’ disease, temporary and permanent recurrent laryngeal nerve palsy and reoperations due to bleeding and the number of inadvertently removed parathyroids as well as changes of endocrine orbitopathies and quality of life. Permanent hypoparythroidism is defined as persisting inadequate parathyroid function exceeding six months after surgery. The incidence of recurrent Graves’ disease is assessed through laboratory thyroid function tests (TSH 6.5 pmol/l, fT4 > 21 pmol/l) and the antibody level of thyroidea receptor anti-body (TRAK > 1.75U/l) six weeks, six months and 12 months after surgery with respect to concomitant substitution or thyreostatic medications to achieve an euthyroid state. Cervical ultrasound follows elevated antibody levels to screen for recurrence. Reoperations are reported as serious adverse events. Incidences of temporary and permanent recurrent laryngeal nerve palsies are assessed through laryngoscopy on the day of discharge and, in case of pathological findings within this examination only, at the six weeks, six months and 12 months after surgery. The number of inadvertently removed parathyroids will be counted from histopathology reports at the day of discharge. In case endocrine orbitopathy can be assumed from medical history and/or clinical examination before and/or 12 months after surgery, an ophthalmologist will check for chracteristics of endocrine orbitopathy . Changes in Quality of life are scored before surgery and 6 weeks thereafter using the validated multipurpose health survey questionnaire SF36.

—

Countries

Germany

Contacts

Public ContactKatja Maschuw

Klinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Gießen und Marburg GmbH- Standort Marburg

maschuw@med.uni-marburg.de0049-(0)6421-58-69897

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 24, 2026