Overview

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

Status:
Unknown status
Trial end date:
0000-00-00
Target enrollment:
150
Participant gender:
Both
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sykehuset Telemark
Collaborator:
Haukeland University Hospital
Treatments:
Antibodies
Hormones
Last Updated:
2014-12-17
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.