The aim of this study was to evaluate the outcome of thyroid surgery with and without drains in patients undergoing total or subtotal or lobectomy of thyroid surgery. Patients that are candidate for thyroid surgury are devided into 2 groups: total- subtotal thyroidectomy and thyroid lobectomy. Each group is randomized into "drain" and "non drain" branch . complications in each group is assesed beteween drain and nondrain group.The sample size is 180 patients. Inclusion criteria for the study, patients undergoing total or subtotal or lobectomy of thyroid surgery. Exclusion criteria retrosternal thyroid, lymph node neck dissection; coagulopathy. These complications include wound related complications such as wound infection and hematoma at the site of action or duration of hospitalization and other complications such as hematoma is required to transfer to the operating room are looking for.The hemovac drain is used and if drainage is less than 30 cc out in 24 hours the drain exited. In the first, the third and the Thirtieth postoperative day, the site of surgery is examined for bleeding, hematoma, seroma and wound infection (redness, swelling, heat, pain, fever and infectious secretions).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030319255N4
Registration date:2016-06-08, 1395/03/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-08, 1395/03/19
Registrant information
Name
Novin Nikbakhsh
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
n.nicbakhsh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials comparison of complications of thyroid surgery with and without drain
Public title
Evaluation of thyroid Surgery Outcomes with and without drain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with a diagnosis of thyroid cancer; Multinodular goiter and thyroid nodules; undergoing total or subtotal or lobectomy of thyroid surgery . Inclusion criteria: patients with a diagnosis of thyroid cancer; Multinodular goiter and thyroid nodules; undergoing total or subtotal or lobectomy of thyroid surgery . pleased to participate in the study; Exclusion criteria were: if patients in the preoperative studies, have an underlying disease (diabetes, cardiovascular disease, etc.); congenital; acquired bleeding disorder; retrosternal thyroid; patients who underwent modified or radical neck dissection or forced to devise the drains were during surgery
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, 180 patients have been assigned to two groups of intervention and control with using random numbers table
Secondary Ids
1
Registry name
www.mubabol.ac.ir
Secondary trial Id
MUBABOL.REC.13940290
Registration date
1994-11-06, 1373/08/15
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Approval date
2015-09-28, 1394/07/06
Ethics committee reference number
30/6636/ژ/پ
Health conditions studied
1
Description of health condition studied
Thyroid diseases caused by iodine deficiency
ICD-10 code
E01
ICD-10 code description
Iodine deficiency related thyroid disorders
Primary outcomes
1
Description
Hematoma surgery
Timepoint
Hospitalization time and first postoperative visit
Method of measurement
Evaluation by surgen or surgical resident
2
Description
Infection surgery
Timepoint
Hospitalization time and first postoperative visit
Method of measurement
Evaluation by surgen or surgical resident
Secondary outcomes
1
Description
Need surgery to drain the hematoma
Timepoint
Hospitalization time and first postoperative visit
Method of measurement
Clinical diagnosis of assistant surgeon or surgical resident
Intervention groups
1
Description
In intervation group, the patients that are condidated for total or subtotal or lobectomy of thyroid surgery is drained.The hemovac drain is passed from below the neck incision. Based on the patient's condition and the amount of fluid; decide to bring out in the days after the operation.
Category
Treatment - Surgery
2
Description
In the control group after thyroid surgery is not drained. Patients are examined days after surgery and are discharged on the basis of general conditions.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Novin Nikbakhsh
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr.Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Asgari Abbaszadeh
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
Asgari2429@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Novin Nikbakhsh
Position
Associated Professer of Surgery
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
novinsu@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Asgari Abbaszadeh
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
Asgari2429@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)