Evaluation of access to kidney stones in patients candidate for PCNL surgery using 3D technology in comparison with X-ray Fluorescopy
Design
Using the online site sealedenvelop.com (the site for sequencing block randomization) The four blocks are randomly assigned to patients in two groups: A: PCNL surgery using three-dimensional technology, and B: PCNL surgery using X-ray fluoroscopy. The order in which the patients are placed to operation model is provided to the technician. The study is Double blind. (Patient and surgeon) 48 patients referred to Sinai Hospital (with ethical consent) are studied. The study is an intervention, phase 3, parallel and therapeutic.
Settings and conduct
This clinical trial will be performed on 82 patients at Sina Hospital. Double blind(Patient and surgeon) Technician (importer of patients in each group based on random blocks) Random blocks, four blocks randomly from patients groups: A: PCNL surgery using three-dimensional technology, and B: PCNL surgery using X-ray fluoroscopy. 12 quadruple blocks are made which are placed in separate envelopes. Randomized blocks are given to a technician.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with kidney stones larger than 15 mm
Indications for PCNL surgery
Exclusion criteria:
Patient dissatisfaction with participation in the research project
Existence of surgical contraindication or CT scan
Intervention groups
Intervention group 1: PCNL surgery using three-dimensional technology
Intervention group 2: PCNL surgery using X-ray fluoroscopy
Main outcome variables
The treatment of stones
General information
Reason for update
Acronym
Percutaneous Nephrolithotomy (PCNL)
IRCT registration information
IRCT registration number:IRCT20200905048625N1
Registration date:2020-09-14, 1399/06/24
Registration timing:registered_while_recruiting
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
seyed reza hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
srhoseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of access to kidney stones in patients candidate for PCNL surgery using 3D technology in comparison with X-ray Fluorescopy
Public title
Access to kidney stones in PCNL surgery using two methods of 3D technology and X-ray fluoroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with kidney stones larger than 15 mm
Indications for PCNL surgery
Exclusion criteria:
Patient dissatisfaction with participation in the research project
Existence of surgical contraindication or CT scan
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a double-blind randomized clinical trial.
For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned.
After the methodologist prepares the randomization sequence using the sealedenvelope online site, the generated sequence will be made available to a technician outside the research team.Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician.The patient is placed in PCNL surgery using 3D technology or in X-ray Fluorescopy group based on the randomly selected envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who have given their consent to participate in the study and Therapist
To perform the blinding process, envelopes related to the type of intervention are provided only to the technician.
The physician is not informed of the type of intervention (PCNL surgery using 3D technology or in X-ray Fluorescopy group) (to avoid bias).
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
2020-08-27, 1399/06/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.373
Health conditions studied
1
Description of health condition studied
kidney stones
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
Intervention group: PCNL surgery using three-dimensional technology -After the initial examination, all patients will have a CT scan without contrast of the abdomen and pelvis to evaluate the condition of the kidney stones (including size, exact location, angle of position), pelvic position, general anatomy of the abdomen and kidneys. CT scan images of patients are entered into Mimix software and a three-dimensional model of the kidney is designed and drawn from CT scan images. Using a 3D digital printer, a three-dimensional model of a kidney, which also includes a kidney stone, is made accurately and in accordance with the actual size, and finally, it is provided to the surgeon. 3D model before PCNL operation by surgeon, examination and preoperative planning for proper access to the stone site, will be done before the actual operation. PCNL surgery will then be performed to treat kidney stones in patients. -Variables of age, sex, pre- and postoperative serum creatinine, pre- and postoperative blood hemoglobin, postoperative bleeding, post-operative blood transfusion need, total PCNL surgery time, stone access time and stone profile will be recorded.
Category
Treatment - Surgery
2
Description
Intervention group: PCNL surgery using X-ray fluoroscopy - PCNL is performed using X-ray fluoroscopy to remove kidney stones by making a small hole through the skin. -This procedure is usually performed under general anesthesia or spinal anesthesia.Technically, in the PCNL method, the needle is passed through the skin to the kidney.The position of the needle is followed by fluoroscopy. With the help of a needle, a guide wire is inserted into the kidney.The needle is then removed, and while the guide wire is still inside the pelvis, a nephroscope is inserted to remove small stones.If the stone is large, it must first be crushed using ultrasound probes and then the stone pieces removed. -Variables of age, sex, pre- and postoperative serum creatinine, pre- and postoperative blood hemoglobin, postoperative bleeding, post-operative blood transfusion need, total PCNL surgery time, stone access time and stone profile will be recorded.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Seyed Reza Hosseini
Street address
Hassan Abad
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
srhoseini@tums.ac.ir
Web page address
http://sinahospital.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 Seyed Reza Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hassan Abad Asqu. Sina Hospital
City
تهران
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8560
Email
srhoseini@tums.ac.ir
Web page address
https://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
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, Dr. Seyed Reza Hosseini 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.