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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Ivar Guldvog, Sykehuset Telemark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02319538
First Posted: December 18, 2014
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Ivar Guldvog, Sykehuset Telemark
  Purpose
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 the absolute total thyroidectomy. 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.

Condition Intervention
Hashimoto's Disease Procedure: Absolute total thyroidectomy performed Drug: medical hormone treatment (Thyroxine)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Treatment of Hashimotos Disease. Effect on Antibodies and Clinical Symptoms.

Resource links provided by NLM:


Further study details as provided by Ivar Guldvog, Sykehuset Telemark:

Primary Outcome Measures:
  • Better outcome in Quality of Life by operation [ Time Frame: 18 months ]
    The patiens are followed for 18 months with blood samples and filling in Quality of Life schemes every 6 months


Secondary Outcome Measures:
  • Lowering of antibodies (Blood samples) [ Time Frame: 18 months ]
    Blood samples every 6 months


Other Outcome Measures:
  • Safety in performing absolute total thyroidectomy (recurrence nerve and long lasting hypocalcemia) [ Time Frame: 12 months ]
    Safety concerning the recurrence nerve and long lasting hypocalcemia. Interim analysis after 75 patients.

  • Interim analysis after 75 patients concerning safety (recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples) [ Time Frame: 12 months ]
    The patients operated upon are investigated after 12 months concerning safety. The recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples.


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Non-surgical treatment only
This arm receives standard medical hormone treatment, but no surgical intervention.Thyroxine supplementation
Drug: medical hormone treatment (Thyroxine)
Medical hormon treatment with individual dosage
Other Name: Thyroxine
Active Comparator: Absolute total thyroidectomy performed
Surgical arm. Absolute total thyroidectomy is performed.
Procedure: Absolute total thyroidectomy performed
Surgery combined with standard thyroxine treatment
Other Name: Thyroxine

Detailed 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 an absolute total thyroidectomy is 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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319538


Contacts
Contact: Ivar Guldvog, MD, PhD 97076342 ext 0047 ivar.guldvog@sthf.no

Locations
Norway
Telemark Hospital Trust, surgical department Recruiting
Skien, Norway, 3710
Contact: Ivar Guldvog, MD, PhD    97076342 ext 0047    ivar.guldvog@sthf.no   
Principal Investigator: Ivar Guldvog, MD, PhD         
Sponsors and Collaborators
Sykehuset Telemark
Haukeland University Hospital
Investigators
Principal Investigator: Ivar Guldvog, MD, PhD Sykehuset Telemark
  More Information

Responsible Party: Ivar Guldvog, Consultant, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT02319538     History of Changes
Other Study ID Numbers: DTG 031100-031230
First Submitted: December 15, 2014
First Posted: December 18, 2014
Last Update Posted: December 18, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Hashimoto Disease
Thyroiditis, Autoimmune
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Antibodies
Hormones
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists