Clips versus Ligatures in Thyroid Surgery: a randomised controlled trial

niversity of Heidelberg Medical School (Germany)0 个研究点目标入组 420 人开始时间: 2003年12月22日最近更新: 2017年10月30日

适应症

试验速览

暂无简介。

•The trial population consists of hospitalised patients of the four participating Departments of Surgery, who are planned for an elective thyroid operation. These operations can be performed with either the clip vessel ligation technique or the conventional clamp-tie technique.
•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
•At the end of surgical exploration:
•? Suitable for at least 2/3 resection of the thyroid

•Malignant disease or high 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

发起方

niversity of Heidelberg Medical School (Germany)