By reducing the interval between thyroidectomy and radioiodine ablation therapy in patients sick leave time of the patients can be reduced and the quality of life improved. Furhermore costs will for society will be lower.
ID
Bron
Verkorte titel
Aandoening
Differentiated thyroid cancer.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Days of sick leave reported from time of surgery.
Achtergrond van het onderzoek
The initial treatment of patients with differentiated thyroid cancer (DTC) consists of total thyroidectomy followed by thyroid remnant radioiodine ablative therapy (RIT). For successful RIT, elevated levels of thyroid stimulating hormone (TSH) are required. Before the introduction of recombinant human TSH (rhTSH) patients were withheld thyroid hormone substitution therapy for 4 weeks after surgery. Nowadays RIT after rhTSH admission is possible, preventing thyroid hormone withdrawal and subsequent symptoms of hypothyroidism in these patients. Results of RIT after thyroid hormone withdrawal and rhTSH stimulation are comparable. RIT with rhTSH stimulation allows planning of the RIT shortly after thyroidectomy.
We hypothesize that with the availability of rhTSH the treatment of DTC patients in a fast track protocol, i.e. RIT shortly after thyroidectomy, will reduce sick leave time, which will lead to a cost reduction for society, and secondly that the fast track treatment will lead to a higher quality of life for the patients during treatment. Patients will be sooner ‘back on track’. In this way both society and patients will benefit from the implementation of the fast track protocol.
Doel van het onderzoek
By reducing the interval between thyroidectomy and radioiodine ablation therapy in patients sick leave time of the patients can be reduced and the quality of life improved. Furhermore costs will for society will be lower.
Onderzoeksopzet
Continuous monitoring of sick leave and quality of life from start of treatment until 2 months after therapy.
Onderzoeksproduct en/of interventie
Standard treatment: Thyroidectomy followed by a 4-6 week during waiting period and then ablation with radioactive iodine.
Interventional treatment: Thyroidectomy directly followed by radioactive iodine ablation.
Publiek
UMC Utrecht <br>
Postbus 85500
J.W. Kist
Utrecht 3508 GA
The Netherlands
+31 (0)6 41853004
j.w.kist@umcutrecht.nl
Wetenschappelijk
UMC Utrecht <br>
Postbus 85500
J.W. Kist
Utrecht 3508 GA
The Netherlands
+31 (0)6 41853004
j.w.kist@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with proven differentiated thyroid cancer, stage T1-3N0-1M0;
2. Planned for total or completion thyroidectomy;
3. Paid job; at least 12 hours per week;
4. Capable of understanding Dutch questionnaires and keeping a diary.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnant or breastfeeding patients;
2. T4 (i.e. tumor expansion in vital structures) or M1 tumors;
3. Contrast enhanced CT performed < 4 months prior to inclusion;
4. Hypersensitivity to bovine serum albumin, rhTSH or to any of the excipients;
5. Dialysis-dependent end stage renal disease.
Opzet
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In overige registers
Register | ID |
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NTR-new | NL3747 |
NTR-old | NTR3933 |
CCMO | NL41880.041.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON39885 |