Prophylactic use of mesh in closure of abdominal wall in kidney transplant patients
Design
Clinical trial with simple control and randomization group
Settings and conduct
The effect of using mesh in closing the abdominal wall in kidney transplant patients in Imam Reza Hospital, Tabriz
Participants/Inclusion and exclusion criteria
Prophylactic use of mesh in closure of abdominal wall in kidney transplant patients
Intervention groups
Prophylactic use of mesh in closure of abdominal wall in kidney transplant patients
Main outcome variables
Reduction of postoperative incisional hernia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211129053218N1
Registration date:2022-02-05, 1400/11/16
Registration timing:registered_while_recruiting
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Mohammad Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3230 0217
Email address
dr.jafariiiii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-11, 1399/09/21
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic use of mesh in closure of abdominal wall in kidney transplant patients
Public title
Prophylactic use of mesh in closure of abdominal wall
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having kidney transplant conditions
No history of abdominal hernia surgery
Exclusion criteria:
No history of abdominal hernia surgery
Lack of conditions for kidney transplantation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done in such a way that the names of the patients who were candidates for kidney transplantation that were registered in the computer were divided into two groups completely randomly.
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz, Eram town, Behesht street, in front of the police station, 21 second alley, number 3
City
Tabriz
Province
East Azarbaijan
Postal code
5147953111
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.1115
Health conditions studied
1
Description of health condition studied
Prophylactic use of mesh in closure of abdominal wall in kidney transplant patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of the effect of using mesh in closing the abdominal wall in kidney transplant patients
Timepoint
Up to one year after surgery
Method of measurement
Contacting patients and examining patients once every three months
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Prevention
2
Description
Control group:
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
emam reza hospital, transplant ward
Full name of responsible person
phd afshar zomorrodi
Street address
daneshgah st,emam reza hospital
City
tabriz
Province
East Azarbaijan
Postal code
41561789103
Phone
+98 41 3467 8967
Email
zomorrodia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
University Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۶۶
Phone
+98 41 3337 6925
Fax
+98 41 3336 4659
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
2
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Position
Vice Chancellor for Research, University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Tabriz University Street, University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
4166614766
Phone
+98 41 3337 6925
Fax
+98 41 3336 4659
Email
info@medfac.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad jafari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tabriz, Eram town, Behesht street, in front of the police station, 21 second alley, No. 3
City
Tabriz
Province
East Azarbaijan
Postal code
5147953111
Phone
01432300217
Email
dr.jafariiiii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Afshar Zomordi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Tabriz Imam Reza Hospital Urology Department
City
Tabriz
Province
East Azarbaijan
Postal code
5147953111
Phone
00981441147229
Email
dr.jafariiiii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Microdata will not be published
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, the results will be reported in the form of an article
When the data will become available and for how long
One year after completing the study for one year
To whom data/document is available
public
Under which criteria data/document could be used
In the form of an article and due to the use of other results by other experts
From where data/document is obtainable
To reputable scientific sources to download the article
What processes are involved for a request to access data/document
Refer to reputable internet sources and download the article