Comparison of sexual dysfunction in renal transplant recipients with the internal and external iliac anastomosis
Design
A double-blind clinical trial, with parallel, randomized groups, on 60 patients, used random allocation software for randomization.
Settings and conduct
Double-blind (participant and data analyzer). Male and married patients under 60 years of age are candidates for kidney transplant surgery by two methods of internal and external iliac artery anastomosis in September and October of 2020 in Khorshid and Al-Zahra centers of Isfahan who are satisfied to participate in the study and if during surgery or They die during the study, have a transplant rejection, are unable to access them for any reason, or do not want to continue participating in the study. They are excluded from the study using random assignment software to two groups of internal iliac artery anastomoses. And are divided externally. The number of samples in each group is 30. At the final visit before surgery, the IIEF questionnaire will be provided to them. Six months and one year after each surgery, the IIEF questionnaire is completed again by the patients. Subsequently, all information is entered in SPSS 23 statistical software and analyzed by repeated measures statistical test and post hoc tests.
Participants/Inclusion and exclusion criteria
Married male patients less than 60 years old who are candidates for kidney transplant surgery will be examined by two methods of internal and external iliac artery anastomosis who are willing to participate in the study. Patients who died during surgery or the follow-up period were rejected during the study, for whatever reason are reluctant to continue the study, or are not available for follow-up after surgery are excluded from the study.
Intervention groups
Two surgical methods of internal and external iliac artery anastomosis
Main outcome variables
Sexual dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200804048296N1
Registration date:2020-08-06, 1399/05/16
Registration timing:prospective
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Amir Javid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3234 9802
Email address
amirjavid@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-10-01, 1399/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sexual dysfunction in renal transplant recipients with the internal and external iliac anastomosis
Public title
sexual dysfunction in renal transplant with the internal and external iliac anastomosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for kidney transplant surgery using internal and external iliac artery anastomosis methods
Married male patients
less than 60 years old
Have consent to participate in the study
Exclusion criteria:
Patients whose long-term follow-up is not possible for any reason, such as distance from home
Age
To 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software to divide patients into two groups, internal and external iliac artery anastomosis
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: they do not know about arterial anastomosis method (internal or external iliac) in their kidney transplant surgery.
Data analyzer: does not know what surgical procedure each of the data relates to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Hezarjarib street
City
isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2020-08-02, 1399/05/12
Ethics committee reference number
IR.MUI.MED.REC.1399.363
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual ability score in the International Index of Erectile Function (IIEF) questionnaire
Timepoint
Before kidney transplant surgery, 6 months and one year after
Method of measurement
International Index of Erectile Function (IIEF) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of end-to-end internal iliac artery anastomosis for blood supply to a transplanted kidney in kidney transplant surgery
Category
Treatment - Surgery
2
Description
Control group: Use of end-to-side external iliac artery anastomosis for blood supply to a transplanted kidney in kidney transplant surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Amir Javid
Street address
Shohada-ye-sofe street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
amirjavid@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Amir Javid
Street address
Hashtbehesht street
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3303 3740
Email
amirjavid@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooyejavanmard
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Javid
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohada-ye-sofe street, Al-zahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009836685555
Email
amirjavid@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Javid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No 18, khorram street, isfahan, iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 9802
Fax
Email
amirjavid@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Javid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No 18, khorram street, isfahan, iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 9802
Fax
Email
amirjavid@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the IIEF questionnaire of the studied patients
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Only for researchers working in academic institutions
Under which criteria data/document could be used
The terms of use of the data have not yet been decided.
From where data/document is obtainable
Dr. Amir Javid (Executor)
amirjavid@med.mui.ac.ir
What processes are involved for a request to access data/document
Sending an email to the project manager, investigating the reason for requesting the data by the project manager, the research council of the urology department and the university