- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey, 34843
- Maltepe University School of Medicine, General Surgery Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients required thyroidectomy
Exclusion Criteria:
- Patients with substernal goitre or non differentiated cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
thyroidectomy
|
total thyroidectomy or lobectomy
|
Active Comparator: Group 2
thyroidectomy use of drain
|
total thyroidectomy or lobectomy
drain will be used
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Postoperative first 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6th hours and 24th hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
postoperative first 6th hour, 24th hour, third day, third month, sixth month, first year
|
Length of hospital stay
Time Frame: postoperative period (days)
|
Use of drain increases length of hospital stay.
|
postoperative period (days)
|
Collaborators and Investigators
Sponsor
Investigators
- 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: Rahmi Çubuk, Ass.Prof., Maltepe University, School of Medicine, Radiology Department
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mütf2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Goiter
-
Steen BonnemaCompleted
-
Genzyme, a Sanofi CompanyCompletedMultinodular GoiterCanada, United States, France, Brazil, Italy, Denmark, Germany, Netherlands
-
Cliniques universitaires Saint-Luc- Université...Completed
-
University Hospital, RouenCompletedGoiter, NodularFrance
-
Hospital Universitari de BellvitgeUnknown
-
Oklahoma State UniversityCompletedInfant Development | Iodine Deficiency GoiterEthiopia
-
Jagiellonian UniversityCompleted
-
Jan CalissendorffRecruiting
Clinical Trials on Thyroidectomy
-
Aristotle University Of ThessalonikiAHEPA University HospitalCompleted
-
Second Military Medical UniversityUnknown
-
Kahramanmaras Sutcu Imam UniversityCompletedThyroid Diseases | Thyroid Cancer | Thyroid Nodule | Thyroid Neoplasms Benign
-
University of AlbertaTerminated
-
Assiut UniversityUnknown
-
Centre Hospitalier Universitaire de NīmesTerminatedGraves Disease | Goiter | Thyroid Nodule | ThyroiditisFrance
-
University of Colorado, DenverCharite University, Berlin, GermanyTerminatedHypothyroidism | Postsurgical HypothyroidismUnited States
-
Tel-Aviv Sourasky Medical CenterCompletedPapillary Thyroid Cancer | Well Differentiated Thyroid Carcinoma
-
Jagiellonian UniversityCompleted