Comparing mini perc outcome and (RIRS ) Retrograde Intrarenal Surgery) in treating remaining post-PCNL (Percutaneous Nephrolithonomy) stones>2 cm or Hounsfield>1000 or SSD(Skin Stone Distance)>10 cm
Design
A clinical trial with two groups of patients: 120 Patient, parallel, therapeutic, simple random, single-blind
Settings and conduct
A simple randomized clinical trial, single-blind(patients), 120 patients, Sina Hospital,
Case Study: Patients with residual stones after PCNL over 2cm or Hounsfield over 1000 or SSD over 10cm
After completing the written consent, they will be placed in one of two groups of mini perc or RIRS.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with residual stones after PCNL over 2cm
2- Hounsfield over 1000
3- SSD over 10cm
Exclusion criteria:
Cases that have Systemic Inflammatory Response Syndrome (SIRS).
Intervention groups
RIRS Surgery (Retrograde Intrarenal Surgery),
Mini perc surgery
Main outcome variables
complications, hospitalization time, surgical time, and success rate of complete stone therapy.
General information
Reason for update
Acronym
RIRS (Retrograde Intrarenal Surgery)
IRCT registration information
IRCT registration number:IRCT20190624043991N5
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
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
2019-09-15, 1398/06/24
Expected recruitment end date
2020-09-14, 1399/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing mini perc outcome and RIRS in treating remaining post-PCNL stones>2 cm or Hounsfield>1000 or SSD(Skin Stone Distance)>10 cm
Public title
Mini perc and RIRS surgery for stone treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with residual stones after PCNL over 2cm
Hounsfield over 1000
SSD over 10 cm
Exclusion criteria:
Cases that have Systemic Inflammatory Response Syndrome (SIRS).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of patients for each surgery is done by simple randomization without patient intervention. Patients were randomly assigned to Balance block randomization.
For this purpose, randomization sequences were determined using the sealedenvelop.com site by assigning two groups A (intervention) and B (control), block size 4 and sample size 120.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who have given their consent to participate in the study will be treated with SIRS or mini perc.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees in Medical Medical Research
Street address
Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-01-24, 1398/11/04
Ethics committee reference number
IR.TUMS.VCR.REC.1398.835
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
Treatment of urinary stones(Kidney stones)
Timepoint
One month after surgery (mini perc and RIRS )
Method of measurement
Spiral CT scan of the abdomen and pelvis, before and after surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mini perc The "mini-perc" technique of percutaneous nephrolithotomy, which uses the 14-Fr peel-away sheath, is a safe and effective modality for treating renal calculi. On the other hand, the "mini-perc" as percutaneous nephrolithotomy achieved through a sheath too small to accommodate a standard rigid nephroscope.
Category
Treatment - Surgery
2
Description
Intervention group: RIRS Retrograde Intra Renal Surgery (RIRS): In this method, a flexible urethroscope breaks the stones into crushing fragments. In this procedure, no incision is made on the patient's body and the patient can be discharged immediately after 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
١١٣٦٧٤٦٩١١
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
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Re-information for the purpose of clarification
Using data by referring to the article's original
Get permission from the author of the article and the presenter
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir
00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.