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

Completed

Conditions: Secondary hyperparathyroidism
Nutritional, Metabolic, Endocrine
Hyperparathyroidism

Registration Number: ISRCTN86202793

Lead Sponsor: Medical Faculty Philipps-University (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of recurrent sHPT

Secondary Outcome Measures

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