Is the Use of Drain for Thyroid Surgery Realistic?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
manuk norayk manukyan, Maltepe University
ClinicalTrials.gov Identifier:
NCT01771523
First received: August 3, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention
Goiter
Procedure: Thyroidectomy
Device: use of drain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Official Title: Is the Use of Drain for Thyroid Surgery Realistic?

Resource links provided by NLM:


Further study details as provided by Maltepe University:

Primary Outcome Measures:
  • Postoperative fluid accumulation (ml.) [ Time Frame: Postoperative first 24 hours ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 6th hours and 24th hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    Use of drain increases length of hospital stay.


Enrollment: 400
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients required thyroidectomy

Exclusion Criteria:

  • Patients with substernal goitre or non differentiated cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771523

Locations
Turkey
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
  More Information

Additional Information:
No publications provided

Responsible Party: manuk norayk manukyan, Associated Professor, Maltepe University
ClinicalTrials.gov Identifier: NCT01771523     History of Changes
Other Study ID Numbers: mütf2
Study First Received: August 3, 2011
Last Updated: January 16, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Maltepe University:
thyroidectomy
drain use

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014