Clips versus Ligatures in Thyroid Surgery

Not Applicable

Completed

Conditions: Thyroid surgery
Surgery

Registration Number: ISRCTN96901396

Lead Sponsor: niversity of Heidelberg Medical School (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 420

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br><br>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.