Back to resultsIs the Use of Drain for Thyroid Surgery Realistic?
Primary Purpose
Goiter
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thyroidectomy
use of drain
Sponsored by
About this trial
This is an interventional screening trial for Goiter focused on measuring thyroidectomy, drain use
Eligibility Criteria
Inclusion Criteria:
- All patients required thyroidectomy
Exclusion Criteria:
- Patients with substernal goitre or non differentiated cancer
Sites / Locations
- Maltepe University School of Medicine, General Surgery Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
thyroidectomy
thyroidectomy use of drain
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01771523
Brief Title
Is the Use of Drain for Thyroid Surgery Realistic?
Official Title
Is the Use of Drain for Thyroid Surgery Realistic?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goiter
Keywords
thyroidectomy, drain use
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
thyroidectomy
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
thyroidectomy use of drain
Intervention Type
Procedure
Intervention Name(s)
Thyroidectomy
Intervention Description
total thyroidectomy or lobectomy
Intervention Type
Device
Intervention Name(s)
use of drain
Intervention Description
drain will be used
Primary Outcome Measure Information:
Title
Postoperative fluid accumulation (ml.)
Description
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.
Time Frame
Postoperative first 24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain score on the visual analog scale (0-10)
Description
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.
Time Frame
6th hours and 24th hours
Other Pre-specified Outcome Measures:
Title
Number of postoperative complications.
Description
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.
Time Frame
postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year
Title
Length of hospital stay
Description
Use of drain increases length of hospital stay.
Time Frame
postoperative period (days)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients required thyroidectomy
Exclusion Criteria:
Patients with substernal goitre or non differentiated cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uğur Deveci, Ass. Prof.
Organizational Affiliation
Maltepe University, School of Medicine , General Surgery Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuk N. Manukyan, Ass.Prof.
Organizational Affiliation
Maltepe University, School of Medicine, General Surgery Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abut Kebudi, Prof.
Organizational Affiliation
Maltepe University, School of Medicine, General Surgery Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatih Altintoprak, Ass.Prof.
Organizational Affiliation
Sakarya University, School of Medicine, General Surgery Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neşe Yener, Ass.Prof.
Organizational Affiliation
Maltepe University, School of Medicine, Pathology Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sertan Kapakli, Ass.Prof.
Organizational Affiliation
Maltepe University, School of Medicine, General Surgery Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahmi Çubuk, Ass.Prof.
Organizational Affiliation
Maltepe University, School of Medicine, Radiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maltepe University School of Medicine, General Surgery Department
City
İstanbul
ZIP/Postal Code
34843
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
23819100
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed?term=Arriyanayagam%20DC%2C%20Narayan%20Singh%20V%2C%20Busby%20D%2C%20Sieunarine%20K%2C%20Raju%20G%3A%20Thyroid%20surgery%20without%20drainage%3B%2015%20years%20of%20clinical%20experience.%20Journal%20of%20Royal%20
Description
Thyroid surgery without drainage: 15 years of clinical experience.
URL
http://www.ncbi.nlm.nih.gov/pubmed/15946379
Description
Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153].
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2276675/
Description
Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders.
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Is the Use of Drain for Thyroid Surgery Realistic?
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