Investigating the effect of normal saline irrigation temperature on surgical outcomes of patients undergoing percutaneous nephrolithotomy
Design
A double-blind, randomized clinical trial study with parallel groups and phases 3 on 50 patients.Patients will be randomly divided into groups using generated-computer numbers by Random Allocation software.
Settings and conduct
This study will be conducted in patients undergoing PCNL in Urmia Imam Khomeini Hospital. Patients will be flushed with a cold or warm solution during PCNL. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into two groups.
Participants/Inclusion and exclusion criteria
In this study, 50 patients between 18 and 60 years old undergoing PCNL will included. Patients with kidney stones with a diameter of more than 2-3 cm, stones resistant to lithotripsy with extracorporeal shock wave, proximal ureter stones with a diameter of more than 1.5 cm, and diverticular stones will not be included in the study.
Intervention groups
Patients in one group will be washed with cold washing solution (20-24°C) and in the other group will be washed with warm solution (25-29°C) during PCNL.
Main outcome variables
Stone free rate; duration of surgery; complications; hypothermia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N11
Registration date:2023-10-27, 1402/08/05
Registration timing:prospective
Last update:2023-10-27, 1402/08/05
Update count:0
Registration date
2023-10-27, 1402/08/05
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of normal saline irrigation temperature on surgical outcomes of patients undergoing percutaneous nephrolithotomy
Public title
Investigating the effect of normal saline irrigation temperature in patients undergoing percutaneous nephrolithotomy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with kidney stones with a diameter of more than 2-3 cm
Patients with stones resistant to extracorporeal shock wave lithotripsy
Patients with proximal ureter stones with a diameter of more than 1.5 cm
Diverticular stones
Age between 18 and 60 years
Exclusion criteria:
Coagulation disorders
Severe heart failure
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to one of the hot or cold wash solution groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization" will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups.Thus, the randomization process will continue until the final sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into two groups. Washing process will be performed during percutaneous nephrolithotomy (PCNL) by a urologist (other than the outcome assessor) and finally the name of groups will be encoded with the letters A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini University hospital- Urmia University of MedicalSciences