Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TOPAR
Study hypothesis
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
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).
Study design
Multicentre, randomised, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Frequency of recurrent sHPT
Secondary outcome measures
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
Overall trial start date
01/11/2006
Overall trial end date
30/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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)
Recruitment start date
01/11/2006
Recruitment end date
30/11/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Dept. for Visceral, Thoraxic and Vascular Surgery
Marburg
35033
Germany
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (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
Basic results (scientific)
Publication list