Is the Use of Drain for Thyroid Surgery Realistic?

Goiter Clinical Trial

Official title:

Is the Use of Drain for Thyroid Surgery Realistic?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771523
• Other study ID #: mütf2
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: January 16, 2013
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients required thyroidectomy

Exclusion Criteria:

• Patients with substernal goitre or non differentiated cancer

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Goiter

Intervention

Procedure:
• Thyroidectomy
total thyroidectomy or lobectomy

Device:
• use of drain
drain will be used

Locations

Country	Name	City	State
Turkey	Maltepe University School of Medicine, General Surgery Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of postoperative complications.	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.	postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year	Yes
Other	Length of hospital stay	Use of drain increases length of hospital stay.	postoperative period (days)	No
Primary	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	Yes
Secondary	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	No

External Links

•   Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders.
•   Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153].
•   Thyroid surgery without drainage: 15 years of clinical experience.