Trial no.:	PACTR202607520333163	Date of Registration:	09/07/2026
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Cold saline irrigation vs room temperature saline irrigation in RIRS.

Official scientific title

Cold Saline Irrigation in Retrograde Intrarenal Surgery: A Prospective Randomized Comparative Study.

Brief summary describing the background and objectives of the trial

Retrograde intrarenal surgery (RIRS) requires continuous irrigation to maintain visualization; however, prolonged procedures for renal stones 2-3 cm may increase intrarenal pressure and thermal injury, potentially leading to infectious and renal complications.Treatment of renal stones measuring 2–3 cm usually requires prolonged operative time, exposing renal tissue to prolonged thermal stress and elevated intrarenal pressure despite the use of ureteral access sheaths, so to prevent the effect of direct thermal injury to the renal cell, we use a cold saline irrigation which cause Vasoconstriction to the venous systems and lymphatics decreasing the backflow to the circulation which is the main cause of postoperative UTI and sepsis . Accordingly, the aim of the present study is to compare the safety and efficacy of using cold saline irrigation during RIRS for renal calculi between 2 cm and 3 cm, with particular focus on postoperative UTI and quality of the endoscopic surgical field.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Kidney Disease,Urological and Genital Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Surgery

Anticipated trial start date

01/09/2025

Actual trial start date

01/11/2025

Anticipated date of last follow up

25/08/2026

Actual Last follow-up date

11/08/2026

Anticipated target sample size (number of participants)

260

Actual target sample size (number of participants)

236

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Allocation was determined by the holder of the sequence who is situated off site	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Retrograde intrarenal surgery using saline at room temperature irrigation	Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization	Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes	Patients in this group undergo retrograde intrarenal surgery (RIRS) using standard commercial normal saline fluid maintained and delivered at stable room temperature (approximately 20–25°C) for endourological irrigation.	118	Active-Treatment of Control Group
Experimental Group	Retrograde intrarenal surgery using cold saline irrigation.	Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization	Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes	Patients in this group undergo retrograde intrarenal surgery (RIRS) using cold saline irrigation at approximately 3–5°C for endourological irrigation with low power laser settings ( 12- 18 W ) in dusting mode	118
Control Group	Retrograde intrarenal surgery using saline at room temperature irrigation	Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization	Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes	Patients in this group undergo retrograde intrarenal surgery (RIRS) using standard commercial normal saline fluid maintained and delivered at stable room temperature (approximately 20–25°C) for endourological irrigation.	118	Active-Treatment of Control Group
Experimental Group	Retrograde intrarenal surgery using cold saline irrigation.	Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization	Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes	Patients in this group undergo retrograde intrarenal surgery (RIRS) using cold saline irrigation at approximately 3–5°C for endourological irrigation with low power laser settings ( 12- 18 W ) in dusting mode	118

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Age: from 20 to 60 years · Sex: male and female. Pelvicalyceal single stone 2 to 3 cm	Patients with solitary kidney or bilateral urolithiasis. Active UTI Patients with distal ureteric obstruction . Renal stones on Anomalous kidney Uncompansated Coagulopathy.	Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	20 Year(s)	60 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

28/09/2025

Research Ethics Committee Banha Faculty of Medicine

Ethics Committee Address
Street address	City	Postal code	Country
El-Shaheed Farid Nada, Qism Banha	Banha	6470201	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Decreasing the intrarenal temperature to prevent postoperative urinary tract infection after RIRS	1 week
Primary Outcome	The clarity of the endoscopic surgical field according to visualization scale	During the procedure
Secondary Outcome	Stone free rate via post operative Pelviabdomenal Ultrasound and CT	3 weeks
Secondary Outcome	Renal thermal injury evaluated by Biochemical markers ( Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Molecule-1 ) secreted by parenchymal cells via blood sample Preoperative and postoperative	24 hours

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Benha University Hospital	El-Shaheed Farid Nada, Qism Banha	Banha	6470201	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Benha University Hospital	El-Shaheed Farid Nada, Qism Banha	Banha	6470201	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Faculty of Medicine Benha University	El-Shaheed Farid Nada, Qism Banha, Banha	Banha	6470201	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Public Enquiries	Mahmoud Abdelhamid Elshamy	dr.mahmoud.elshamy.5797@gmail.com	+201028495275	Arramla
City	Postal code	Country	Position/Affiliation
Benha	13722	Egypt	Urology Resistant
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed Abdelrahman Alhefnawy	mohamed.alhefnawy@fmed.bu.edu.eg	+201003481084	Zefta, Gharbia Governorate
City	Postal code	Country	Position/Affiliation
Gharbia Governorate	6660180	Egypt	Professor at urology department Banha University
Role	Name	Email	Phone	Street address
Principal Investigator	Mahmoud Abdelhamid Elshamy	dr.mahmoud.elshamy.5797@gmail.com	+201028495275	Arramla
City	Postal code	Country	Position/Affiliation
Banha	13722	Egypt	Urology Resistant at National Institute of Urology and Nephrology
Role	Name	Email	Phone	Street address
Public Enquiries	Mahmoud Abdelhamid Elshamy	dr.mahmoud.elshamy.5797@gmail.com	+201028495275	Arramla
City	Postal code	Country	Position/Affiliation
Benha	13722	Egypt	Urology Resistant
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed Abdelrahman Alhefnawy	mohamed.alhefnawy@fmed.bu.edu.eg	+201003481084	Zefta, Gharbia Governorate
City	Postal code	Country	Position/Affiliation
Gharbia Governorate	6660180	Egypt	Professor at urology department Banha University
Role	Name	Email	Phone	Street address
Principal Investigator	Mahmoud Abdelhamid Elshamy	dr.mahmoud.elshamy.5797@gmail.com	+201028495275	Arramla
City	Postal code	Country	Position/Affiliation
Banha	13722	Egypt	Urology Resistant at National Institute of Urology and Nephrology

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Individual participant data will not be shared. Informed consent obtained from participants did not include provisions for the sharing of de-identified individual participant data with external researchers	Study Protocol	Not applicable as there are no plans to share individual participant data.	Not applicable as there are no plans to share individual participant data.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial phase	22/06/2026	the phase of the trial is not applicable as no drugs or vaccine used , it is a surgical intervention.	Phase-1	Not Applicable
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Purpose of the trial	22/06/2026	The study includes surgical intervention.	Treatment: Other	Treatment: Surgery
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Anticipated date of last follow up	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	31 Jul 2026	25 Aug 2026
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Completion date	19/08/2026	The Study is now complete.		11 Aug 2026
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Target no of participants	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	238	260
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	190	236
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	Closed to recruitment,follow-up continuing	Recruiting
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	Recruiting	Closed to recruitment,follow-up continuing
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	19/08/2026	The Study is now complete.	Closed to recruitment,follow-up continuing	Completed
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Disease(s)	22/06/2026	the trial related to kidney diseases ( renal stones )	Urological and Genital Diseases	Urological and Genital Diseases, Kidney Disease
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	Control Group, Retrograde intrarenal surgery using saline at room temperature irrigation, Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization, Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes, Patients in this group undergo retrograde intrarenal surgery (RIRS) using standard commercial normal saline fluid maintained and delivered at stable room temperature (approximately 20–25°C) for endourological irrigation., 95, Active-Treatment of Control Group	Control Group, Retrograde intrarenal surgery using saline at room temperature irrigation, Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization, Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes, Patients in this group undergo retrograde intrarenal surgery (RIRS) using standard commercial normal saline fluid maintained and delivered at stable room temperature (approximately 20–25°C) for endourological irrigation., 118, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	05/08/2026	We increased the number of patients from 95 to 118 , as a minimum of 118 patients per group (236 total) was required to detect this difference between the two groups based on the incidence of postoperative urinary tract infection (UTI) reported by Kasahara et al., in which the cold saline group had a UTI incidence of 7.4% compared to 19.7% in the room-temperature group. Assuming a two-sided alpha of 0.05 and a power of 80%	Experimental Group, Retrograde intrarenal surgery using cold saline irrigation., Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization, Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes, Patients in this group undergo retrograde intrarenal surgery (RIRS) using cold saline irrigation at approximately 3–5°C for endourological irrigation with low power laser settings ( 12- 18 W ) in dusting mode , 95,	Experimental Group, Retrograde intrarenal surgery using cold saline irrigation., Continuous manually adjusted irrigation at rate of 20 ml/ minute during the procedure as needed for visualization, Intraoperative : after insertion of Ureteral access sheath for identification of the stone till the end of stone fragmentation . average operative time is 60-90 minutes, Patients in this group undergo retrograde intrarenal surgery (RIRS) using cold saline irrigation at approximately 3–5°C for endourological irrigation with low power laser settings ( 12- 18 W ) in dusting mode , 118,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	02/07/2026	wrong data entry	Primary Outcome, The clarity of the endoscopic surgical field according to visualization scale , During the percedure	Primary Outcome, The clarity of the endoscopic surgical field according to visualization scale , During the procedure
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	20/08/2026	the ethics approval letter from the ethics committee	TRUE, Research Ethics Committee Banha Faculty of Medicine, El-Shaheed Farid Nada, Qism Banha, Banha, 6470201, Egypt, , 28 Sep 2025, +201158652937, ethical.committee@fmed.bu.edu, 41515_38815_4737.pdf	TRUE, Research Ethics Committee Banha Faculty of Medicine, El-Shaheed Farid Nada, Qism Banha, Banha, 6470201, Egypt, , 28 Sep 2025, +201158652937, ethical.committee@fmed.bu.edu, 41515_38815_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Funding Source	FundingSources List	22/06/2026	Wrong data entry.		Benha University Hospital, El-Shaheed Farid Nada, Qism Banha, Banha, 6470201, Egypt, University,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Contact People	Contacs List	19/08/2026	Wrong data.	Public Enquiries, Mahmoud Abdel hameed, Elshamy, Dr., dr.mahmoud.elshamy.5797@gmail.com, dr.ma7moud.elshamy@gmail.com, +201028495275, Arramla, Benha , 13722, Egypt, Urology Resistant	Public Enquiries, Mahmoud Abdelhamid, Elshamy, Dr., dr.mahmoud.elshamy.5797@gmail.com, dr.ma7moud.elshamy@gmail.com, +201028495275, Arramla, Benha , 13722, Egypt, Urology Resistant
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Contact People	Contacs List	20/08/2026	Wrong data	Scientific Enquiries, Mohamed Abdel rahman, Alhefnawy, Prof., mohamed.alhefnawy@fmed.bu.edu.eg, dr.mohamedalhefnawy@gmail.com, +201003481084, Zefta, Gharbia Governorate, Gharbia Governorate, 6660180, Egypt, Professor at urology department Banha University	Scientific Enquiries, Mohamed Abdelrahman, Alhefnawy, Prof., mohamed.alhefnawy@fmed.bu.edu.eg, dr.mohamedalhefnawy@gmail.com, +201003481084, Zefta, Gharbia Governorate, Gharbia Governorate, 6660180, Egypt, Professor at urology department Banha University
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Contact People	Contacs List	22/06/2026	Wrong Contacts entery		Principal Investigator, Mahmoud Abdel hameed , Elshamy, Dr., dr.mahmoud.elshamy.5797@gmail.com, mahmoud150378@fmed.bu.edu.eg, +201028495275, Arramla, Banha, 13722, Egypt, Urology Resistant at National Institute of Urology and Nephrology
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Contact People	Contacs List	19/08/2026	Wrong Contact entry	Principal Investigator, Mahmoud Abdel hameed , Elshamy, Dr., dr.mahmoud.elshamy.5797@gmail.com, mahmoud150378@fmed.bu.edu.eg, +201028495275, Arramla, Banha, 13722, Egypt, Urology Resistant at National Institute of Urology and Nephrology	Principal Investigator, Mahmoud Abdelhamid, Elshamy, Dr., dr.mahmoud.elshamy.5797@gmail.com, mahmoud150378@fmed.bu.edu.eg, +201028495275, Arramla, Banha, 13722, Egypt, Urology Resistant at National Institute of Urology and Nephrology
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	22/06/2026	Upon final review of the institutional review board (IRB) approved informed consent forms, it was determined that participant consent did not include authorization to share de-identified individual participant data with external researchers	De-identified individual participant data that underlie the results reported in the final article (including text, tables, and figures) will be made available to researchers who provide a methodologically sound proposal.	Individual participant data will not be shared. Informed consent obtained from participants did not include provisions for the sharing of de-identified individual participant data with external researchers
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD-Sharing time frame	22/06/2026	Upon final review of the institutional review board (IRB) approved informed consent forms, it was determined that participant consent did not include authorization to share de-identified individual participant data with external researchers	Data will become available beginning 6 months after publication of the main study results and will remain available for up to 3 years	Not applicable as there are no plans to share individual participant data.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	22/06/2026	Upon final review of the institutional review board (IRB) approved informed consent forms, it was determined that participant consent did not include authorization to share de-identified individual participant data with external researchers	Data requests should be directed to the corresponding author. To gain access, requestors will need to sign a data access agreement and provide an approved research protocol.	Not applicable as there are no plans to share individual participant data.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Study protocol document	22/06/2026	Upon final review of the institutional review board (IRB) approved informed consent forms, it was determined that participant consent did not include authorization to share de-identified individual participant data with external researchers	Study Protocol, Informed Consent Form	Study Protocol

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