Is the Use of Drain for Thyroid Surgery Realistic?

Study Overview
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Brief Summary
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Background : The use of suction drains in thyroid surgery is common practice in order to avoid haematoma or seroma, as well as to identify promptly the onset of haemorrhaging that might compromise the patient's airway. The aim of this study to determine the effects of routine drainage compared to no drainage in thyroidectomy patients. Study Design : Total of 400 patients who undergoing total thyroidectomy or lobectomy for thyroidal disorders will be randomly allocated to be drained or not. Postoperative ultrasonographic (USG) neck examination will be performed for all patients on postoperative 24th hour by the same ultrasonologist each time. Postoperative pain, complications and hospital stay will be recorded. The statistical analysis will be performed and p<0,05 will be accepted as an important statistical value (SPSS 16.0 for Windows).

Detailed Description
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Patients will include in the study will randomly allocate to drain and non-drain group on the basis of computer generated random number table. Patients with substernal goitre or non differentiated cancer will exclude from the study. According to the thyroidal disorder, total thyroidectomy or lobectomy plus isthmectomy will be performed. The operating time will be defined as the time from the first incision to the last suture's placement. 4/0 polypropylene sutures will be used subcutaneously for wound closure. In the drain group a closed suction drain with negative pressure (Hemovac®) was brought out through a separate wound.

Official Title
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Is the Use of Drain for Thyroid Surgery Realistic?

Conditions
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Goiter

Intervention / Treatment
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* Procedure: Thyroidectomy
* Device: use of drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients required thyroidectomy Exclusion Criteria: Patients with substernal goitre or non differentiated cancer
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>thyroidectomy | Procedure: Thyroidectomy<br>* total thyroidectomy or lobectomy<br>|
| Active Comparator: Group 2<br>thyroidectomy use of drain | Procedure: Thyroidectomy<br>* total thyroidectomy or lobectomy<br>Device: use of drain<br>* drain will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative fluid accumulation (ml.) | Standard thyroidectomy is proven method for safety. We will perform standard thyroidectomy in this study. In this period, patients will be monitored for bleeding and seroma. Major bleeding rare complication for thyroid surgery but requires re-operation immediately. Many studies suggested that drains may block with clotted blood and do not alert the surgeon, even if major bleeding occurs(1,2,3). We don't use drain routinely in standard thyroidectomy in our clinic for seven years. Bleeding and reoperation rates are similar between the literature and our clinic. The amount of fluid collection in thyroid bed will be assessed by Ultrasonography in postoperative 24th hours. Volume of fluid collection in the operative bed will be calculated by measuring the maximum diameter in three dimensions.Similar results between groups are evidence that the use of drain is not necessary. | Postoperative first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score on the visual analog scale (0-10) | Postoperative pain will be assessed according to a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) on the postoperative sixth hour (POSH-VAS) and postoperative first day (POFD-VAS).The mean VAS scores will be compared drain and non-drain group. | 6th hours and 24th hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, drain use