Evaluation of success rate of kidney stone crushing based on body mass index and patient's condition during stone crushing
Design
A clinical trial with two groups of patients: parallel, therapeutic, simple randomization. 84 patients referred to Sinai Hospital.
Settings and conduct
This clinical trial will be performed on 84 patients at Sina Hospital. Patients are divided into two groups of surgery and the quality of treatment results is evaluated. After completing the written consent, they will be placed in one of two groups of Supine and Prone Positions in Percutaneous Nephrolithotomy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the study. Candidate for prone PCNL surgery. Presence of Renal or Upper Ureteral Stone. Exclusion criteria: Patients with Cardiovascular disease. Patients with Coagulation disorders. Acute Infection Urosepsis. Presence of Acute Renal Failure.
Intervention groups
Intervention group1: Supine Positions in Percutaneous Nephrolithotomy. Intervention group2: Prone Positions in Percutaneous Nephrolithotomy.
Main outcome variables
Accuracy of calyx access, the success of extracorporeal lithotripsy in kidney stones in Supine and Prone Positions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N17
Registration date:2022-06-03, 1401/03/13
Registration timing:prospective
Last update:2022-06-03, 1401/03/13
Update count:0
Registration date
2022-06-03, 1401/03/13
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
2022-06-10, 1401/03/20
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of success rate of kidney stone crushing based on body mass index and patient's condition during stone crushing
Public title
Evaluation of success rate of kidney stone crushing based on body mass index and patient's condition
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
presence of renal or upper ureteral stone
Consent to participate in the study
Exclusion criteria:
Patients with cardiovascular disease
presence of acute renal failure
Patients with coagulation disorders
acute infection Urosepsis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a randomized clinical trial.
A simple randomization method and a random number table is used. In this way, a number will be selected randomly, if the number is even, the patient will enter the intervention group and if the number is odd, the patient will enter the second group. The researcher selects one of the numbers randomly, moves in one of the predetermined directions, records the numbers and assigns them to different groups.
Even Number: Patients undergoing Percutaneous nephrolithotomy surgery (Supine Positions)
odd Number: Patients undergoing Percutaneous nephrolithotomy surgery with (Prone Positions )
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 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
2021-01-30, 1399/11/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1035
Health conditions studied
1
Description of health condition studied
Renal and ureteral stones
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
Accuracy of calyx access
Timepoint
During operation
Method of measurement
Observation by nephroscope and fluroscopy during operation
Secondary outcomes
1
Description
The success of extracorporeal lithotripsy in kidney stones in Supine and Prone Positions
Timepoint
In two rounds one and two months after extracorporeal lithotripsy
Method of measurement
Ultrasound and CT scan
Intervention groups
1
Description
Intervention group: Supine Positions in Percutaneous Nephrolithotomy
Category
Treatment - Surgery
2
Description
Intervention group: Prone Positions in Percutaneous Nephrolithotomy
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
Urology Research Center - Sina Hospital - Hassan Abad St. - Tehran - Iran
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. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran, Iran.
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
Medical Biology
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
Medical Biology
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
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
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.