Comparison of blood loss and complications in patients underwent percutaneous nephrolithotomy with balloon traction of nephrostomy and conventional methods: a randomized clinical trial
A clinical trial to compare the amount of bleeding and surgical complications of percutaneous nephrolithotomy in a group that had a balloon nephrostomy compared to a normal nephrostomy
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 102 patients.
Settings and conduct
Labbafinejad Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: kidney stone candidate for PCNL surgery
Age 18 years and older
Placement in group one ASA 1,2 in terms of anesthesia risk
Exclusion criteria:
Age less than 18 years
Patients with kidney stones with anatomical abnormalities (malrotation, pelvic kidney and horseshoe kidney)
Patients with kidney parenchymal atrophy and kidney with little function
Placement in ASA grade 3 group in terms of anesthesia risk
Patients with high creatinine (<1.5 mg/dL)
BMI greater than 30
Untreated coagulation disorder
Aspirin consumption in the last seven days
Taking NSAID drugs in the last 5 days
Untreated active urinary tract infection
Intervention groups
In the first group, a balloon nephrostomy was placed under fluoroscopy control at the infundibulum entrance of the access site from the pelvic side, and with a brief traction on the balloon, tamponade will performed on the calyx of the access site. In the second group, which is the control group, the nephrostomy point is implanted in the conventional way. Then the hemoglobin decrease and complications in these two groups will compared.
Main outcome variables
Stone clearance, transfusion rate, hemoglobin changes, urinary leakage volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160406027253N2
Registration date:2023-10-02, 1402/07/10
Registration timing:registered_while_recruiting
Last update:2023-10-02, 1402/07/10
Update count:0
Registration date
2023-10-02, 1402/07/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 88644466
Email address
ahkashi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of blood loss and complications in patients underwent percutaneous nephrolithotomy with balloon traction of nephrostomy and conventional methods: a randomized clinical trial
Public title
A clinical trial to compare the amount of bleeding and surgical complications of percutaneous nephrolithotomy in a group that had a balloon nephrostomy compared to a normal nephrostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney stones are candidates for PCNL surgery
Age 18 years and older
Placement in group one ASA I,II in terms of anesthesia risk
Exclusion criteria:
Age under 18 years old
Patients with kidney stones with anatomical abnormalities(Renal malrotation, pelvic kidney, horseshoe kidney
Paranchymal atrophy and kidney with little function
Placement in group one ASA III in terms of anesthesia risk
High Creatinine
BMI over 30 Kg/m2
Untreated coagulation disorder
Aspirin consumption in the last 7 days
Taking NSAID drugs in the last 5 days
Untreated active urinary tract infection
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process has already been done by Stata software, and the number of patients has been divided into binary and quadruple blocks by using the Random allocation command in Stata, and the patient number and the group in which the random allocation is placed in the sealed envelopes. At the end of the operation, the envelopes are opened and based on the contents of the envelope, a normal nephrostomy or a balloon nephrostomy is placed inside the pelvis and the balloon is filled a little and then traction is applied on the skin to put pressure on the calyx of the access site.
Blinding (investigator's opinion)
Double blinded
Blinding description
Equality of nephrostomy ends outside body ensures the unawareness of participants to allocation groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kidney Diseases Research Center- Shahid Beheshti University of Sciences
Street address
No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Approval date
2022-12-25, 1401/10/04
Ethics committee reference number
IR.SBMU.UNRC.REC.1401.030
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N 20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Stone cleaning
Timepoint
24 hours after the intervention
Method of measurement
Plain radiography of the abdomen
2
Description
Transfusion Rate
Timepoint
From the start of surgery until time of discharge from the hospital
Method of measurement
The number of units of blood transfused during hospitalization
3
Description
Urinary leak volume
Timepoint
During hospitalization
Method of measurement
CC volume of urine removed from the nephrostomy site
4
Description
Changes in hemoglobin
Timepoint
End of operation and 24 hours after surgery
Method of measurement
mg/dL based on laboratory measurement
Secondary outcomes
1
Description
creatinine change
Timepoint
preoperative and 24-48 hours after surgery
Method of measurement
based on serum levels of creatinine before and after operation
2
Description
hospitalization duration
Timepoint
from hospitalization to discharge
Method of measurement
days
Intervention groups
1
Description
Intervention group: In the intervention group, a balloon nephrostomy was placed under fluoroscopy at the infundibulum entrance of the access site from the pelvic side, and tamponade was performed on the calyx of the access site with brief traction on the balloon.
Category
Treatment - Surgery
2
Description
Control group: In the control group, which is the control group, the nephrostomy point was inserted in the conventional way. Then the hemoglobin drop and complications in these two groups were compared.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Labafinejad Hospital
Full name of responsible person
Dr. Amirhossein Kashi
Street address
No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Email
ahkashi@gmail.com
Web page address
https://lamc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Basiri
Street address
Pasdaran st., 9th Boustan st.,
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2277 0954
Email
info@unrc.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Kashi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Email
ahkashi@gmail.com
Web page address
https://lamc.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Nouralizadeh
Position
Asssociate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Email
ahkashi@gmail.com
Web page address
https://lamc.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Kashi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 8016
Email
ahkashi@gmail.com
Web page address
https://lamc.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Non-secret data of the study will be published in the official website of the Urology and Nephrology Research Center and will be accessible for all people for 5 years.
When the data will become available and for how long
Non-secret data of the study will be published in the official website of the Urology and Nephrology Research Center and will be accessible for all people for 5 years.
To whom data/document is available
Non-secret data of the study will be published in the official website of the Urology and Nephrology Research Center and will be accessible for all researchers for 5 years.
Under which criteria data/document could be used
Will be dependent of the policy of the journal in which the article will be published.
From where data/document is obtainable
unrc website stated above
What processes are involved for a request to access data/document
request on website --> confirmation by UNRC manager --> access given