Total parathyroidectomy without autotransplantation and without thymectomy compared to total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism (sHPT): a randomised controlled multicentred pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86202793

Enrollment

100

Registered

2006-08-22

Start date

2006-11-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Secondary hyperparathyroidism Nutritional, Metabolic, Endocrine Hyperparathyroidism

Interventions

Group one: total parathyroidectomy without thymectomy and without autotransplantation (TPTX) Group two: total parathyroidectomy with thymectomy and with autotransplantation (TPTX+AT)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Intact Parathyroid Hormone (PTH) more than or equal to a tenfold value above normal value 2. Age equal to or greater than 18 years 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Primary or tertiary hyperparathyroidism (hyperparathyroidism after kidney transplantation) 2. Familiary hyperparathyroidism (MEN I, MEN II, hereditary hyperparathyroidism) 3. History of neck explorations for thyroid/parathyroid disease 4. Malignant disease of the thyroid glands 5. Bleeding disorder/coagolupathy 6. Severe psychiatric or neurologic diseases 7. Drug- and/or alcohol-abuse 8. Participation in another interventional-trial with interference of intervention and outcome 9. Inability to follow the instructions given by the investigator (e.g. insufficient command of language)

Design outcomes

Primary

Measure	Time frame
Frequency of recurrent sHPT	—

Secondary

Measure	Time frame
1. Intraoperative: 1.1. Duration of surgical procedure 1.2. Expertise of responsible surgeon (estimated number of parathyroidectomies performed) 1.3. Complications and findings (number of parathyroid glands found, recurrent laryngeal nerve injury) 2. Post-operative until discharge: 2.1. Frequency of persistent hyperparathyroidism 2.2. Morbidity (e.g. bleeding, recurrent laryngeal nerve palsy) 2.3. Length of hospital stay 3. Discharge until 36 months follow up: 3.1. Frequency of recurrent sHPT 3.2. Frequency of autotransplantation due to refractory hypoparathyroidism 3.3. Frequency of reexploration of the neck or of the parathyroid autograft 3.4. Frequency of irreversible recurrent laryngeal nerve palsy 3.5. Follow up of clinical symptoms related to sHPT (change over time) 3.6. Change in quality of life 3.7. Death	—

Measure

Time frame

1. Intraoperative: 1.1. Duration of surgical procedure 1.2. Expertise of responsible surgeon (estimated number of parathyroidectomies performed) 1.3. Complications and findings (number of parathyroid glands found, recurrent laryngeal nerve injury) 2. Post-operative until discharge: 2.1. Frequency of persistent hyperparathyroidism 2.2. Morbidity (e.g. bleeding, recurrent laryngeal nerve palsy) 2.3. Length of hospital stay 3. Discharge until 36 months follow up: 3.1. Frequency of recurrent sHPT 3.2. Frequency of autotransplantation due to refractory hypoparathyroidism 3.3. Frequency of reexploration of the neck or of the parathyroid autograft 3.4. Frequency of irreversible recurrent laryngeal nerve palsy 3.5. Follow up of clinical symptoms related to sHPT (change over time) 3.6. Change in quality of life 3.7. Death

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026