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Completed

NCT Number: NCT01771523

Is the Use of Drain for Thyroid Surgery Realistic?

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).

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Key information

Conditions

Goiter Endocrine System Diseases Thyroid Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maltepe University School of Medicine, General Surgery Department

Istanbul, 34843, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients required thyroidectomy

Exclusion criteria

  • Patients with substernal goitre or non differentiated cancer

Treatment and study plan

Thyroidectomy

Procedure

total thyroidectomy or lobectomy

use of drain

Device

drain will be used

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. Length of hospital stay

    Time frame: postoperative period (days)

    Use of drain increases length of hospital stay.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2013
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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