Is the Use of Drain for Thyroid Surgery Realistic?
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 thyroidectomy |
Procedure: Thyroidectomy
total thyroidectomy or lobectomy
|
| Active Comparator: Group 2 thyroidectomy use of drain |
Procedure: Thyroidectomy
total thyroidectomy or lobectomy
Device: use of drain
drain will be used
|
Outcome Measures
Primary Outcome Measures
- Postoperative fluid accumulation (ml.) [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.
Secondary Outcome Measures
- Postoperative pain score on the visual analog scale (0-10) [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.
Other Outcome Measures
- Number of postoperative complications. [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 [postoperative period (days)]
Use of drain increases length of hospital stay.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients required thyroidectomy
Exclusion Criteria:
- Patients with substernal goitre or non differentiated cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maltepe University School of Medicine, General Surgery Department | İstanbul | Turkey | 34843 |
Sponsors and Collaborators
- Maltepe University
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Thyroid surgery without drainage: 15 years of clinical experience.
- Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153].
- Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders.
Publications
None provided.- mütf2