Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

NCT07655050 | Not Yet Recruiting DMC

• 1 other identifier: ETIK-2026-22
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.

Conditions

Kidney Stones Renal Calculi Postoperative Infectious Complications Urinary Tract Infection Sepsis Systemic Inflammatory Response Syndrome

Keywords

Retrograde intrarenal surgery (RIRS), Kidney stone, Gentamicin, Irrigation fluid, Infectious complications, Urinary tract infection, Sepsis

Outcome Measures

Primary Outcomes (3)

• Postoperative Fever

  Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.

  Within 48 hours after surgery

• Systemic Inflammatory Response Syndrome

  Systemic inflammatory response syndrome will be defined as the presence of at least two of the following criteria: body temperature greater than 38°C or less than 36°C, heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, or white blood cell count greater than 12,000/mm³ or less than 4,000/mm³.

  Within 48 hours after surgery

• Sepsis

  Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.

  Within 48 hours after surgery

Secondary Outcomes (5)

• Stone-Free Rate

  4 weeks after surgery

• Change in White Blood Cell Count

  Baseline and within 48 hours after surgery

• Change in Serum Creatinine

  Baseline and within 48 hours after surgery

• Urine Culture Positivity

  Within 48 hours after surgery

• Blood Culture Positivity

  Within 48 hours after surgery

Study Arms (4)

Standard RIRS

EXPERIMENTAL

Participants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention.

Procedure: Standard Retrograde Intrarenal Surgery

Standard RIRS With Gentamicin Irrigation

EXPERIMENTAL

Arm Description: Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance.

Procedure: Standard Retrograde Intrarenal Surgery; Drug: Gentamicin Irrigation

Suction RIRS

EXPERIMENTAL

Participants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin.

Device: Suction-Enabled Ureteral Access Sheath

Suction RIRS With Gentamicin Irrigation

EXPERIMENTAL

Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure.

Drug: Gentamicin Irrigation; Device: Suction-Enabled Ureteral Access Sheath

Interventions

Standard Retrograde Intrarenal Surgery PROCEDURE

Standard retrograde intrarenal surgery will be performed under general anesthesia in the lithotomy position. A guidewire will be advanced to the renal pelvis under fluoroscopic guidance, and a ureteral access sheath will be placed when appropriate. Flexible ureteroscopy will be performed, and stones will be fragmented using a holmium laser with the dusting technique. Standard saline irrigation will be used during the procedure.

Also known as: Standard RIRS Flexible Ureteroscopy

Standard RIRS; Standard RIRS With Gentamicin Irrigation

Gentamicin Irrigation DRUG

Gentamicin-containing irrigation fluid will be used during retrograde intrarenal surgery. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline irrigation solution. This intervention will be used as a local intraoperative irrigation strategy to reduce bacterial contamination within the renal collecting system and is not intended as systemic antibiotic treatment.

Also known as: Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:

Standard RIRS With Gentamicin Irrigation; Suction RIRS With Gentamicin Irrigation

Suction-Enabled Ureteral Access Sheath DEVICE

A suction-enabled ureteral access sheath will be used during retrograde intrarenal surgery in the suction groups. The device is intended to improve fluid evacuation from the renal collecting system, reduce intrarenal pressure, and facilitate removal of irrigation fluid, stone dust, and debris during flexible ureteroscopy.

Also known as: Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath

Suction RIRS; Suction RIRS With Gentamicin Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones
• Male and female patients aged 18 years or older
• Patients who voluntarily sign the informed consent form
• Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile

You may not qualify if:

• Patients with active urinary tract infection before surgery
• Patients with chronic kidney disease
• Pregnant patients
• Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin
• Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye

Çorum, Çorum, 19040, Turkey (Türkiye)

Location

Related Publications (3)

• Zhong W, Leto G, Wang L, Zeng G. Systemic inflammatory response syndrome after flexible ureteroscopic lithotripsy: a study of risk factors. J Endourol. 2015 Jan;29(1):25-8. doi: 10.1089/end.2014.0409.

  PMID: 24999535 BACKGROUND

• Rai A, Aro T, Lynch E, Tabib C, Mikhail D, Wang D, Abraham A, Hoenig D, Smith A, Okeke Z. Novel Irrigation Protocol for Renal Pelvis Sterilization During Percutaneous Nephrolithotomy: A Pilot Study. J Endourol. 2021 Sep;35(9):1320-1325. doi: 10.1089/end.2020.0695. Epub 2021 May 10.

  PMID: 33752442 BACKGROUND

• Corrales M, Sierra A, Doizi S, Traxer O. Risk of Sepsis in Retrograde Intrarenal Surgery: A Systematic Review of the Literature. Eur Urol Open Sci. 2022 Aug 30;44:84-91. doi: 10.1016/j.euros.2022.08.008. eCollection 2022 Oct.

  PMID: 36071820 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Calculi; Urinary Tract Infections; Sepsis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Central Study Contacts

MUSTAFA SERDAR ÇAĞLAYAN

CONTACT

+90 507 431 1951; serdar.09.09@hotmail.com

AHMET TAŞCI

CONTACT

+905531596690; ahmettasci400@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized into four parallel study arms using a 2×2 factorial design. The two factors evaluated in the study are gentamicin-containing irrigation and the use of a suction-enabled ureteral access sheath during retrograde intrarenal surgery. This design will allow assessment of the independent effects of each intervention as well as their combined effect on postoperative infectious complications.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): February 8, 2027
• Study Completion (Estimated): May 8, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)