Comparison of RIRS (Retrograde Intrarenal Surgery) by Under Vision and Under Fluoroscopic Injection
Design
A clinical trial with two groups of patients: parallel, therapeutic, simple random, single blind
Settings and conduct
Prior to the study, tests will be performed on patients referred to Sina Hospital, including platelet count and white blood cell count. After the study is completed, they will be re-tested and data collected. Also, surgical complication rate will be assessed by ureteral examination after ureteral sheath removal with Rigid Toxic Ureteroscope. The infection will be assessed by examining the patients' fever rates, and finally, after six weeks of contrast-enhanced abdominal and pelvic CT scans to evaluate the success rate of surgery and after three months of IVP surgery to evaluate ureteral stenosis. Finally, statistical analysis is performed using SPSS software version 24 and the success and side effects of the two groups are compared using chi-square and Fisher tests and length of stay by independent t-test.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Referral to Sina Hospital; Patients Candidate for RIRS
Stones between 1 to 2 cm in the upper, middle and pelvic cavities; stones below 2 cm in the lower calyx;
Stones that have not responded to eswl treatment.
Exclusion criteria:
These included bleeding diseases
Intervention groups
Under Vision and Under Fluoroscopic Injection
Main outcome variables
Includes hospitalization time Sheet implantation time as well as ureteral injury as assessed by ureteroscopy after surgery and CT scan three months after surgery, and success rate in complete stone therapy, which was determined by CT scan three months later.
General information
Reason for update
Acronym
RIRS (Retrograde Intrarenal Surgery)
IRCT registration information
IRCT registration number:IRCT20190624043991N3
Registration date:2019-12-31, 1398/10/10
Registration timing:registered_while_recruiting
Last update:2019-12-31, 1398/10/10
Update count:0
Registration date
2019-12-31, 1398/10/10
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of RIRS (Retrograde Intrarenal Surgery) by Under Vision and Under Fluoroscopic Injection In patients, the candidate is RIRS
Public title
Comparison of RIRS (Retrograde Intrarenal Surgery) by Under Vision and Under Fluoroscopic Injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have stones of between 1 and 2 cm in the middle of the upper ciliary and pelvic cavities and below 1 cm inches of lower calis.
Stones that have not responded to ESWL treatment
Exclusion criteria:
Patients affected by hemorrhagic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used will be simple randomization. And the random number table will be used. If a number is randomly selected we will move to the right according to the preset contract and if the number even comes in The patient will be admitted to the intervention group and if the number comes in, the patient will be included in the second group (Assigning patients under Under Vision and Under Fluoroscopic Injection based on couple and individual referral number).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who have agreed to participate in the study will undergo RIRS in either of two ways, Under Vision or Fluoroscopic Guidance. Participants are unaware of the RIRS procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research in Tehran University of Medical Sciences
Street address
Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
IR.TUMS.VCR.REC.1398.550
Health conditions studied
1
Description of health condition studied
Urethral stone
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
Primary outcomes
1
Description
Kidney stone removal
Timepoint
Once a month
Method of measurement
CT-scan
Secondary outcomes
empty
Intervention groups
1
Description
RIRS (Retrograde Intrarenal Surgery) performed with a flexibile ureterorenoscope is one of the new methods used to treat urinary stones. Intervention group:Under Vision(New method as an alternative to fluoroscopy)
Category
Treatment - Surgery
2
Description
RIRS (Retrograde Intrarenal Surgery) performed with a flexible ureterorenoscopy is one of the new methods used to treat urinary stones. Intervention group:Under Fluoroscopic Injection: Fluoroscopic guides are a useful and effective method of determining the correct position of the needle. Fluoroscopy is a simple and accessible tool that can be used in all pain control procedures during surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Hassan Abad
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran. Keshavarz Boulevard, Quds Ave., Central University, Sixth Floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
registrant
Under which criteria data/document could be used
Re-information for the purpose of clarification
From where data/document is obtainable
Dr Seyed Mohammad Kazem Aghamir
What processes are involved for a request to access data/document
After the examination, the applicant will be provided with the advice of an epidemiologist and with the confidentiality of patient information.