Hashimoto - a Surgical Disease. Total Thyroidectomy Makes Antibodies Disappear and Ameliorates Symptoms

Hashimoto's Disease Clinical Trial

Official title:

Surgical Treatment of Hashimotos Disease. Effect on Antibodies and Clinical Symptoms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319538
• Other study ID #: DTG 031100-031230
• Status: Completed
• Phase: N/A
• First received: December 15, 2014
• Last updated: January 12, 2018
• Start date: February 13, 2012
• Est. completion date: July 15, 2017

Study information

• Verified date: January 2018
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients referred due to typical symptoms, believed to be related to Hashimoto´s disease, but not relieved by thyroxin substitution. Optimal thyroid substitution treatment is already provided.

2. Anti-TPO>1000

3. Hypothyroidism with a need for thyroxin supplementation

4. Written informed consent by the patient - information particularly emphasising and quantifying the risk of complications (e.g. recurrent laryngeal nerve palsy). The patient should be informed by a medical endocrinologist as well as a surgeon.

Exclusion Criteria:

1. Patients <18 years of age.

2. Pregnancy.

3. Unable to comprehend information adequately to give informed consent.

4. General anaesthesiological contraindications.

5. An unexpected finding of cancer in the surgical group is not a reason for exclusion per se, but this group should be analyzed separately. It is expected that any different loading in Quality of life would bias the medically treated group.

Related Conditions & MeSH terms

• Hashimoto Disease
• Hashimoto's Disease

Intervention

Procedure:
• Total thyroidectomy performed
Surgery combined with standard thyroxine treatment

Locations

Country	Name	City	State
Norway	Telemark Hospital Trust, surgical department	Skien

Sponsors (3)

Lead Sponsor	Collaborator
Sykehuset Telemark	Haukeland University Hospital, Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Interim analysis after 75 patients concerning safety (recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples)	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
Primary	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
Secondary	Lowering of antibodies (Blood samples)	Blood samples every 6 months	18 months