Is the Use of Drain for Thyroid Surgery Realistic?
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|ClinicalTrials.gov Identifier: NCT01771523|
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Goiter||Procedure: Thyroidectomy Device: use of drain||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Is the Use of Drain for Thyroid Surgery Realistic?|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: Group 1
total thyroidectomy or lobectomy
Active Comparator: Group 2
thyroidectomy use of drain
total thyroidectomy or lobectomyDevice: use of drain
drain will be used
- Postoperative fluid accumulation (ml.) [ Time Frame: Postoperative first 24 hours ]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 pain score on the visual analog scale (0-10) [ Time Frame: 6th hours and 24th hours ]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.
- Number of postoperative complications. [ Time Frame: postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year ]We will demonstrate there was no significant differences in postoperative complications between subgroups.Similar complications rates will be demonstrate absence of drains for thyroid surgery is safe and efficient.
- Length of hospital stay [ Time Frame: postoperative period (days) ]Use of drain increases length of hospital stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771523
|Maltepe University School of Medicine, General Surgery Department|
|İstanbul, Turkey, 34843|
|Principal Investigator:||Uğur Deveci, Ass. Prof.||Maltepe University, School of Medicine , General Surgery Department|
|Study Director:||Manuk N. Manukyan, Ass.Prof.||Maltepe University, School of Medicine, General Surgery Department|
|Study Chair:||Abut Kebudi, Prof.||Maltepe University, School of Medicine, General Surgery Department|
|Principal Investigator:||Fatih Altintoprak, Ass.Prof.||Sakarya University, School of Medicine, General Surgery Department|
|Principal Investigator:||Neşe Yener, Ass.Prof.||Maltepe University, School of Medicine, Pathology Department|
|Principal Investigator:||Sertan Kapakli, Ass.Prof.||Maltepe University, School of Medicine, General Surgery Department|
|Principal Investigator:||Rahmi Çubuk, Ass.Prof.||Maltepe University, School of Medicine, Radiology Department|