The aim of this study is to compare the two positions of prone and flank in PCNL surgery in people with a body mass index (BMI) above 30 kg/m2.
Design
Two arm parallel group randomised trial with outcome assessment of 70 patients with balanced block randomization in single center
Settings and conduct
PCNL will be carried out in prone or flank positions under general anesthesia by single surgical team. Cystoscopic ureteral catheterization and retrograde ureterographic fluoroscopy will help to find the pyelocalyceal anatomy. Puncture will be done with an 18 Gage needle with standard technique. A J tip wire will pass from the needle into the pyelocalyceal system Then dilatation wil be done to 30 Fr. Nephroscopy will be conducted by KARL STORZ Nephroscope (27092 AMA with 26 Fr. Sheat) and stones was fragmented by pneumatic lithotripter. After extraction of stones, nephroscopy site will be sutured and a ureteral catheter was left in ureter. Double j stent will be inserted in some cases due to indications. Ureteral and Foley catheters will be generally extracted after 48 hours and the patients were discharged.
Participants/Inclusion and exclusion criteria
Inclusion criteria was patient candidate for PCNL who had BMI above 30 kg/m2 and wanted to participate in the study. Exclusion criteria included untreated UTI, history of tumor in access tract, malignant renal tumor, and pregnancy.
Intervention groups
After completing the written consent form entered to study. Patients will be randomly assigned to one of the two groups, Flank or Prone position.
Main outcome variables
The stone free rate (SFR)stent stay day, hospital stay (day), surgery time (min), postoperative complications, creatinine, hemoglobin and hematocrit, and arterial blood gas (PH, HCO3 and PCO2) changes and acid-base hemostasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049303N1
Registration date:2020-12-01, 1399/09/11
Registration timing:registered_while_recruiting
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Ali Mohammad Fakhr Yasseri
Name of organization / entity
Urology research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 5257
Email address
yasseri_2006@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Outcome of Percutaneous Nephrolithotomy in Prone and Flank Position in Obese Patients
Public title
Comparison outcomes of percutaneous nephrolithotomy in prone and flank positions in obese patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient candidate for PCNL who had BMI above 30 kg/m2
Exclusion criteria:
untreated UTI
history of tumor in access tract
malignant renal tumor
pregnancy
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done by blocks of four by using randomization table and individual, without stratified randomization and without allocation concealment.
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
Tehran University of Medical sciences
Street address
7th daliri str. Zafar str. Shariati Str
City
Tehran
Province
Tehran
Postal code
1916665354
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.963
Health conditions studied
1
Description of health condition studied
Kidney stone
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Stone free rate
Timepoint
3 months after discharge
Method of measurement
Ct scan
2
Description
Hospital stay
Timepoint
7 days after intervention
Method of measurement
Hospital document
Secondary outcomes
empty
Intervention groups
1
Description
Firdt intervention group: flank position during percutaneous nephrolithotomy operation , in this operation renal stone is removed using nephroscope by floroscopy guidance without open surgery
Category
Treatment - Surgery
2
Description
Second intervention group: prone position during percutaneous nephrolithotomy operation , , in this operation renal stone is removed using nephroscope by floroscopy guidance without open surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Seyed reza hosseini
Street address
Imam khomeini str.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 6312 6000
Email
yasseri_2006@yahoo.com
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
Seyed reza Hosseini
Street address
Enghelab str
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 6312 6000
Email
yasseri_2006@yahoo.com
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
Seyed Reza Hosseini
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Sina hospital , imam khomeini str.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 6312 6000
Email
Srhoseini@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyes reza Hosseini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Sina hospital, imam khomeini Str.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 912 208 3800
Email
Srhoseini@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Reza Hosseini
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Sina hospital , imam khomeini str.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 6312 6000
Email
Srhoseini@tums.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
No - There is not a plan to make this available
Title and more details about the data/document
Demographic data and outcome of Percutaneous Nephrolithotomy in Prone and Flank Position in Obese Patients
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Academic people
Under which criteria data/document could be used
For clinical studies
From where data/document is obtainable
Dr yasseri
Yasseri_2006@yahoo.com
What processes are involved for a request to access data/document