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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 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.

Detailed Summary:

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.

Sponsor: Sykehuset Telemark

Current Primary Outcome: Better outcome in Quality of Life by operation [ Time Frame: 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Lowering of antibodies (Blood samples) [ Time Frame: 18 months ]

Original Secondary Outcome: Same as current

Information By: Sykehuset Telemark

Dates:
Date Received: December 15, 2014
Date Started: February 2012
Date Completion: February 2016
Last Updated: December 17, 2014
Last Verified: December 2014