The effect of total tubeless PCNL and tubeless PCNL on the outcomes of complete supine percutaneous nephrolithotomy (csPCNL): a single-blind randomized controlled trial
The effect of total tubeless PCNL and tubeless PCNL on the outcomes of complete supine percutaneous nephrolithotomy (csPCNL)
Design
A controlled, parallel-group, single-blind, randomized, phase 2-3 clinical trial on 78 patients. A randomizer software was used for randomization through the online sealed envelope program
Settings and conduct
The study will be performed in the urology ward and operating room of Razi Hospital in Rasht. This study is performed on 78 patients gradually and sequentially. Patients will be randomly divided into two groups: A (tubeless PCNL) and B (total tubeless PCNL). The surgeon does not know the patient group until the operation time. The analyst will also be unaware of the type of patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 20 years
Exclusion criteria: Patients with known metabolic diseases predisposed to stones, transplanted kidney stones, chronic renal failure, anatomical problems (ureteral stricture, duplicate ureter, single kidney, ....)
Intervention groups
Intervention group: In the total tubeless PCNL group, at the end of the procedure, no stent will be implanted for the patient and the patient will be completely tubeless.
Control group: In the tubeless PCNL group, external stents are implanted for all patients after surgery.
The effect of total tubeless PCNL and tubeless PCNL on the outcomes of complete supine percutaneous nephrolithotomy (csPCNL): a single-blind randomized controlled trial
Public title
The effect of total tubeless PCNL and tubeless PCNL on the outcomes of complete supine percutaneous nephrolithotomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 20 years
Consent of patients to participate in the study
Exclusion criteria:
Metabolic disease known to predispose to stones
Transplanted kidney stones
Renal failure requiring chronic dialysis before surgery
Anatomical problems (ureteral stricture, duplicate ureter, single kidney,...)
Bleeding during surgery
Occurrence of any surgical complications during the operation
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 4 through a table of random numbers with a ratio of 1 to 1 (in two groups A and B) using a randomizer through the sealed envelope online program
Blinding (investigator's opinion)
Single blinded
Blinding description
One of the researchers (urology resident) divides the patients into two groups A (tubeless PCNL) and B (total tubeless PCNL) based on the table prepared from random blocks. The surgeon does not know the patient group until the operation time. The analyst will also be unaware of the type of patient grouping. At the top of the checklist that is completed for each patient, the type of group (A or B) is mentioned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Sardar Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Approval date
2022-07-20, 1401/04/29
Ethics committee reference number
IR.GUMS.REC.1401.250
Health conditions studied
1
Description of health condition studied
Postoperative complication of stent
ICD-10 code
Y40-Y59
ICD-10 code description
Drugs, medicaments and biological substances causing adverse effects in therapeutic use
Primary outcomes
1
Description
Postoperative fever
Timepoint
After the operation until the time of discharge
Method of measurement
Examination using a thermometer
2
Description
Postoperative infection
Timepoint
48 hours after surgery
Method of measurement
Lab test and urine culture
3
Description
Postoperative hemoglobin
Timepoint
24 hours after surgery
Method of measurement
Complete blood count (CBC) test
4
Description
Postoperative creatinine
Timepoint
24 hours after surgery
Method of measurement
Blood test by kinetic Jaffe's and enzymatic method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the total tubeless PCNL group, at the end of the procedure, no stent will be implanted for the patient and the patient will be completely tubeless.
Category
Treatment - Surgery
2
Description
Control group: In the tubeless PCNL group, external stents are implanted for all patients after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Siavash Falahatkar
Street address
Sardar-e-Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address
https://urc.gums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Siavash Falahatkar
Street address
Sardar-e-Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc@gums.ac.ir
Web page address
https://urc.gums.ac.ir/
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center, Guilan 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
Rasht University of Medical Sciences
Full name of responsible person
Shahab Aali
Position
Urology resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Sardar-e-Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Email
Shahab.aali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Siavash Falahatkar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Sardar-e-Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Email
falahatkar_s@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Non-faculty researcher
Latest degree
Master
Other areas of specialty/work
Urology
Street address
Sardar Jangal St.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@yahoo.com
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
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