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Table 1 CLIVIT trial: study inclusion and exclusion criteria

From: Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

INCLUSION CRITERIA

EXCLUSION CRITERIA

At study enrollment:

• Age equal or greater than 18 years

• Expected survival time more than 12 months

• Patients with benign diseases of the thyroid gland scheduled for elective surgery

• Euthyroid metabolism (normal level of TSH or T3/T4)

• Normal function of the vocal cords

• Informed consent

• Malignant disease or highly suspicion for malignancy (clinical and imaging evidence)

• Nerve palsy

• Graves' Disease

• Coagulopathy

• Current immunosuppressive therapy

• Chemotherapy within 2 weeks before operation

• Radiotherapy completed no longer than 8 weeks before operation

• Severe psychiatric or neurologic disease

• Drug- and/or alcohol-abuse

• Participation in another intervention-trial with interference of intervention and outcome

• Inability to follow the instructions given by the investigator or the telephone interviewer

• Lack of compliance

At the end of surgical exploration:

• Suitable for at least 2/3 resection of the thyroid

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