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| Name | Class |
|---|---|
| Helse Stavanger HF | OTHER_GOV |
| Haukeland University Hospital | OTHER |
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The investigators have already proven that absolute total thyroidectomy gives elimination of anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. The prerequisite for this effect is that the total thyroidectomy is meticulously performed. There exists no other treatment that can eliminate the antibodies. The study is randomized between operation and ordinary conservative medical treatment with thyroxine control and supplementation. The symptoms in both groups are evaluated by 5 different Quality of Life schemes, internationally approved.
The study hypothesis is that elimination of anti-TPO antibodies ameliorates the typical Hashimoto symptoms like tiredness,increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. It is necessary that the total thyroidectomy is meticulously performed. We have proven the effect on the antibodies, and we have also proven that the operation procedure can be performed without more complications like recurrent nerve damage and hypocalcemia. Neutrality is secured by randomization done by a neutral institution, laryngoscopy by neutral doctors and instructions filling out the QoL-schemes performed by non-biased study nurses.
The study runs for at least 18 months with controls every 6 months. Blood samples are taken and international approved QoL-schemes are filled in. In addition to the randomised main group a side group of patients fulfilling 2 of the 3 inclusion criteria are followed in parallel in order to elucidate the spontaneous development of the disease and showing critical values of antibodies making the symptoms turn up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-surgical treatment only | No Intervention | Control arm. This arm receives standard medical hormone treatment (Thyroxine substitution) only and no surgical intervention. | |
| Total thyroidectomy performed | Active Comparator | Surgical arm.The approach for total thyroidectomy will be a complete removal of all visible, and immunological active thyroid tissue with a high accuracy, with a special focus on three sites; 1) The angle where the recurrent laryngeal nerve enters the cricothyroid membrane, 2) The pyramidal lobe and 3) The hilus where the superior vessels are entering the field. Standard Thyroxine supplementation maintained as in the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total thyroidectomy performed | Procedure | Surgery combined with standard thyroxine treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Better outcome in Quality of Life by operation | The patiens are followed for 18 months with blood samples and filling in Quality of Life schemes every 6 months | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lowering of antibodies (Blood samples) | Blood samples every 6 months | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety in performing absolute total thyroidectomy (recurrence nerve and long lasting hypocalcemia) | Safety concerning the recurrence nerve and long lasting hypocalcemia. Interim analysis after 75 patients. | 12 months |
| Interim analysis after 75 patients concerning safety (recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivar Guldvog, MD, PhD | Sykehuset Telemark | Principal Investigator |
| Hege Kersten, PhD | Sykehuset Telemark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Telemark Hospital Trust, surgical department | Skien | 3710 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30856652 | Derived | Guldvog I, Reitsma LC, Johnsen L, Lauzike A, Gibbs C, Carlsen E, Lende TH, Narvestad JK, Omdal R, Kvaloy JT, Hoff G, Bernklev T, Soiland H. Thyroidectomy Versus Medical Management for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms: A Randomized Trial. Ann Intern Med. 2019 Apr 2;170(7):453-464. doi: 10.7326/M18-0284. Epub 2019 Mar 12. |
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| ID | Term |
|---|---|
| D050031 | Hashimoto Disease |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D013967 | Thyroiditis, Autoimmune |
| D013966 | Thyroiditis |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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The patients operated upon are investigated after 12 months concerning safety. The recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples. |
| 12 months |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |