Clinical trial NCT01771523: Is the Use of Drain for Thyroid Surgery Realistic?
Official title: Is the Use of Drain for Thyroid Surgery Realistic?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goiter
Keywords: thyroidectomy
drain use
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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.

Eligibility criteria: Inclusion Criteria:

* All patients required thyroidectomy

Exclusion Criteria:

* Patients with substernal goitre or non differentiated cancer

Primary outcomes:
measure: Postoperative fluid accumulation (ml.)
timeFrame: Postoperative first 24 hours
Secondary outcomes:
measure: Postoperative pain score on the visual analog scale (0-10)
timeFrame: 6th hours and 24th hours
Other outcomes:
measure: Number of postoperative complications.
timeFrame: postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year
measure: Length of hospital stay
timeFrame: postoperative period (days)
Locations:
city: İstanbul
country: Turkey
facility: Maltepe University School of Medicine, General Surgery Department
Study officials:
affiliation: Maltepe University, School of Medicine , General Surgery Department
name: Uğur Deveci, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University, School of Medicine, General Surgery Department
name: Manuk N. Manukyan, Ass.Prof.
role: STUDY_DIRECTOR
affiliation: Maltepe University, School of Medicine, General Surgery Department
name: Abut Kebudi, Prof.
role: STUDY_CHAIR
affiliation: Sakarya University, School of Medicine, General Surgery Department
name: Fatih Altintoprak, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University, School of Medicine, Pathology Department
name: Neşe Yener, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University, School of Medicine, General Surgery Department
name: Sertan Kapakli, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University, School of Medicine, Radiology Department
name: Rahmi Çubuk, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deveci U, Altintoprak F, Sertan Kapakli M, Manukyan MN, Cubuk R, Yener N, Kebudi A. Is the use of a drain for thyroid surgery realistic? A prospective randomized interventional study. J Thyroid Res. 2013;2013:285768. doi: 10.1155/2013/285768. Epub 2013 May 30.