Thyroid surgery Surgery Thyroid surgery
Conditions
Interventions
The standard surgical approach in both treatment groups will be the Dunhill-Procedure which consists of a hemithyroidectomy and a subtotal thyroidectomy (at least 2/3 of the gland). The randomisation
Sponsors
University of Heidelberg Medical School (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to test whether there is a relevant reduction in operating time (>15 min), using the clip vessel occluding technique versus the conventional clamp-tie. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are divided into surgical and non-surgical categories. In the surgical category there are the following points: total duration of operation (skin incision until suture), weight of specimen, amount of postoperative bleeding, frequency of reoperation due to bleeding, recurrent laryngeal nerve paralysis (temporary or irreversible ? pre- and postoperative assessment of vocal cord function by ENT-specialist), wound infection rate and rate of impaired parathyroid gland function. The non-surgical category consists of duration of postoperative hospital stay. To assess the relevance of the chosen endpoints, the following ten aspects have to be ranked from "most important" to "least important" by patients and surgeons (only once): Intraoperative complications, postoperative complications, length of hospital stay, voice function, dysphagia, death, postoperative pain, postoperative fatigue, convalescence of complete physical maximum resilience and cosmetic result. | — |
Countries
Germany
Outcome results
None listed