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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Dept. for Visceral, Thoraxic and Vascular Surgery
Baldinger Str., Marburg
Marburg
35033
Germany
Study information
| Study design | Multicentre, randomised, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2006 |
| Completion date | 30/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
35033
Germany
Sponsor information
Medical Faculty Philipps-University (Germany)
University/education
University/education
Baldinger Str.
Marburg
35033
Germany
"ROR" |
https://ror.org/01rdrb571 |
|---|
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
06/01/2021: Publication reference added.
