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.
target sample size is 50 patients.
inclusion criteria is patients eligible for total- subtotal thyroidectomy or thyroid lobectomy based on scientific guidelines.
Exclusion criteria is Coagolation disorders,Substernal throid and Cervical lymph node dissection.
Study variables are patients age,gender ,preoperative thyroid size and postoperative complications like postoperative wound site hematoma ,infection,need for postoperative drainage.
These complications are detected by surgical attending and surgical residents early after surgery and at fisrt postoperative visit and are evaluated by statistical metods .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112118373N1
Registration date:2012-01-28, 1390/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-28, 1390/11/08
Registrant information
Name
Seyed Amin Madani
Name of organization / entity
Ahvaz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 545 2538
Email address
madani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Science
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of compliations of thyroid surgery with and without drain
Public title
Efects of drain placement after thyroid surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients eligible for total- subtotal thyroidectomy or thyroid lobectomy based on scientific guidelines.
Exclusion criteria : Coagolation disorders,Substernal throid and Cervical lymph node dissection.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Science
Street address
Ahvaz University of Medical Science-Research Centre
City
Ahvaz
Postal code
Approval date
2011-10-01, 1390/07/09
Ethics committee reference number
eth-247
Health conditions studied
1
Description of health condition studied
Iodine deficienncy related thyroid disorders
ICD-10 code
E01
ICD-10 code description
Iodine deficiency related thyroid disorders
2
Description of health condition studied
non toxic guiter
ICD-10 code
E04
ICD-10 code description
Nontoxic guiter
Primary outcomes
1
Description
wound site hematoma
Timepoint
during hospitalization and first postoperation visit
Method of measurement
evaluation by a surgen or surgical resident
2
Description
need for surgical drainage of hematoma
Timepoint
during hospitalization and first postoperation visit
Method of measurement
evaluation by a surgen or surgical resident
3
Description
surgical site infection
Timepoint
during hospitalization and first postoperation visit
Method of measurement
evaluation by a surgen or surgical resident
4
Description
voice change after operation
Timepoint
during hospitalization and first postoperation visit
Method of measurement
evaluation by a surgen or surgical resident
5
Description
postoperative dispnea
Timepoint
during hospitalization and first postoperative visit
Method of measurement
eviluation by surgen or surgical resident
6
Description
postoperative disphagia
Timepoint
during hospitalization and first postoperative visit
Method of measurement
eviluation by surgen or surgical resident
Secondary outcomes
1
Description
duration of hospital stay
Timepoint
from admission untill discharge
Method of measurement
number of days the patient stays in hospital
Intervention groups
1
Description
Drain is inserted in intervention arm .
Patinents are candidate for total-subtotal thyroidectomy or thyroid lobectomy.
Drain type is vacuum assisted and is taken out depending postoperative condition.
Category
Treatment - Surgery
2
Description
In control arm ,we dont insert any drain.
paitients are discharged based on postoperative evaluation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Amin Madani M.D.
Street address
Saat Square, Amanieh , Razi hosoital
City
Ahvaz
2
Recruitment center
Name of recruitment center
Emam Khomeyni hospital
Full name of responsible person
Amin Madani M.D.
Street address
Azadegan street, Emam Khomeyny hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Science Research Center
Full name of responsible person
Mostafa Feghhi M.D.
Street address
Jondi Shahpoor University, Golestan street,
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Science Research Center
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
Ahvaz Univrsity of Medical Science
Full name of responsible person
Amin Madani M.D.
Position
surgical resident
Other areas of specialty/work
Street address
surgical ward, Emam Khomeyny hospital
City
Ahvaz
Postal code
Phone
+98 912 545 2538
Fax
Email
madani.a@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Science
Full name of responsible person
Amin Madani
Position
surgical resident
Other areas of specialty/work
Street address
surgical ward, Emam Khomeyny hospital
City
Ahvaz
Postal code
Phone
+98 912 545 2538
Fax
Email
madani.a@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Science
Full name of responsible person
Amin Madani M.D.
Position
sugical resident
Other areas of specialty/work
Street address
surgical ward, Emam Khomeyny hospital
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)