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

ISRCTN	ISRCTN86202793
DOI	https://doi.org/10.1186/ISRCTN86202793
Protocol serial number	N/A
Sponsor	Medical Faculty Philipps-University (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

Submission date: 20/07/2006
Registration date: 22/08/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Katja Schlosser
Scientific

Dept. for Visceral, Thoraxic and Vascular Surgery
Baldinger Str., Marburg
Marburg
35033
Germany

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, controlled trial
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	TOPAR
Study objectives	To compare different outcomes between total parathyroidectomy without autotransplantation and without thymectomy (TPTX) and total parathyroidectomy with autotransplantation and with thymectomy (TPTX+AT) over a three year follow up period. On 14/08/2013 Austria was removed from the countries of recruitment, the anticipated end date was changed from 01/05/2011 to 30/11/2013, and the sponsor was changed. The previous sponsor for this trial (up to 14/08/2013) was: Study Centre of the German Surgical Society (SDGC) (Germany) Im Neuenheimer Feld 110 Heidelberg 69120 Germany The current sponsor can be found in the sponsor section below.
Ethics approval(s)	Ethics approval received from the local medical ethics committee (Kommission für Ethik in der Ärztlichen Forschung des Klinikums der Philipps-Universität Marburg) on the 21st August 2006 (ref: 113/06).
Health condition(s) or problem(s) studied	Secondary hyperparathyroidism
Intervention	Group one: total parathyroidectomy without thymectomy and without autotransplantation (TPTX) Group two: total parathyroidectomy with thymectomy and with autotransplantation (TPTX+AT)
Intervention type	Other
Primary outcome measure(s)	Frequency of recurrent sHPT
Key secondary outcome measure(s)	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
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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)
Date of first enrolment	01/11/2006
Date of final enrolment	30/11/2013

Locations

Countries of recruitment

Germany

Study participating centre

Dept. for Visceral, Thoraxic and Vascular Surgery

Marburg
35033
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/09/2007	06/01/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/01/2021: Publication reference added.