Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/07/2006
Date assigned
22/08/2006
Last edited
15/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sdgc.de

Contact information

Type

Scientific

Primary contact

Dr Katja Schlosser

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Medical Faculty Philipps-University (Germany)

Sponsor details

Baldinger Str.
Marburg
35033
Germany

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes