- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07655050
Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS
The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study
연구 개요
상태
상세 설명
Subject:
The present study aims to investigate the effects of gentamicin-containing irrigation and the use of a suction ureteral access sheath during retrograde intrarenal surgery (RIRS) on postoperative infectious complications.
Objective:
The aim of this study is to evaluate the independent and combined effects of gentamicin irrigation and a suction ureteral access sheath on postoperative infectious complications following RIRS.
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive treatment modality for renal stones, particularly for stones up to 20 mm. Although RIRS is generally considered safe and effective, postoperative infectious complications remain an important clinical concern. Fever, urinary tract infection, systemic inflammatory response syndrome (SIRS), and sepsis may occur even in patients with negative preoperative urine cultures and appropriate perioperative antibiotic prophylaxis.
A potential mechanism for infectious complications after RIRS is increased intrarenal pressure during endoscopic lithotripsy. Elevated intrarenal pressure may promote pyelovenous and pyelolymphatic backflow, allowing bacteria, endotoxins, and inflammatory mediators from the collecting system or stone surface to enter the systemic circulation. Therefore, strategies that reduce bacterial contamination within the renal collecting system and improve intrarenal drainage may help decrease postoperative infectious morbidity.
This study is designed to evaluate two intraoperative strategies intended to reduce infectious complications during RIRS. The first strategy is local antibiotic irrigation using gentamicin-containing saline solution. Gentamicin will be added to the irrigation fluid as a local intraoperative measure rather than as a systemic treatment. This approach is intended to reduce bacterial contamination within the collecting system during lithotripsy. All patients will also receive standard systemic antibiotic prophylaxis according to routine clinical practice.
The second strategy is the use of a suction-enabled ureteral access sheath. This device is intended to improve fluid evacuation, reduce intrarenal pressure, and facilitate the removal of stone dust, debris, and potentially contaminated fluid during the procedure. By improving drainage from the collecting system, suction-assisted RIRS may theoretically reduce pyelovenous backflow and the risk of postoperative systemic inflammatory or infectious events.
The study uses a 2×2 factorial design, which allows simultaneous evaluation of the independent effects of gentamicin irrigation and suction-enabled ureteral access sheath use, as well as their combined effect. This design is useful because both interventions target different mechanisms that may contribute to infectious complications: local bacterial contamination and elevated intrarenal pressure. The factorial structure will also allow assessment of whether the combination of these two approaches provides an additive or synergistic benefit compared with either intervention alone.
All procedures will be performed under general anesthesia in the lithotomy position using standard endourological techniques. Irrigation will be performed with normal saline under low-pressure conditions. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline. In the suction groups, a suction-enabled ureteral access sheath will be used during flexible ureteroscopy. Stone fragmentation will be performed with a holmium:YAG laser using a dusting technique, and a double-J ureteral stent will be placed at the end of the procedure according to the study protocol.
This trial may provide clinically relevant evidence regarding infection-prevention strategies in RIRS. If gentamicin irrigation, suction-assisted access sheath use, or their combination is shown to reduce postoperative infectious complications without compromising surgical success, these approaches may contribute to safer perioperative management in endourological stone surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: AHMET TAŞCI
- 전화번호: +905531596690
- 이메일: ahmettasci400@gmail.com
연구 연락처 백업
- 이름: MUSTAFA SERDAR ÇAĞLAYAN
- 전화번호: +90 507 431 1951
- 이메일: serdar.09.09@hotmail.com
연구 장소
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Çorum
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Çorum, Çorum, 터키 (Türkiye), 19040
- Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
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연락하다:
- MUSA EKİCİ
- 전화번호: +90364 222 11 02
- 이메일: tipfak@hitit.edu.tr
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부수사관:
- AHMET TAŞCI
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Standard RIRS
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.
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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.
다른 이름들:
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실험적: Standard RIRS With Gentamicin Irrigation
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. |
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.
다른 이름들:
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.
다른 이름들:
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실험적: Suction RIRS
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.
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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.
다른 이름들:
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실험적: Suction RIRS With Gentamicin Irrigation
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.
|
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.
다른 이름들:
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Fever
기간: Within 48 hours after surgery
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Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.
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Within 48 hours after surgery
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Systemic Inflammatory Response Syndrome
기간: Within 48 hours after surgery
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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.
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Within 48 hours after surgery
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Sepsis
기간: Within 48 hours after surgery
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Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.
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Within 48 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stone-Free Rate
기간: 4 weeks after surgery
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Stone-free status will be evaluated using non-contrast computed tomography.
Residual fragments of 4 mm or less will be considered clinically insignificant.
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4 weeks after surgery
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Change in White Blood Cell Count
기간: Baseline and within 48 hours after surgery
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White blood cell count will be assessed before and after surgery to evaluate postoperative inflammatory response.
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Baseline and within 48 hours after surgery
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Change in Serum Creatinine
기간: Baseline and within 48 hours after surgery
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Serum creatinine levels will be assessed before and after surgery to evaluate renal function changes.
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Baseline and within 48 hours after surgery
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Urine Culture Positivity
기간: Within 48 hours after surgery
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Postoperative urine culture results will be evaluated to identify urinary tract infection and causative microorganisms.
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Within 48 hours after surgery
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Blood Culture Positivity
기간: Within 48 hours after surgery
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Postoperative blood culture results will be evaluated in patients with suspected systemic infection to identify bloodstream infection and causative microorganisms.
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Within 48 hours after surgery
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ETIK-2026-22
개별 참가자 데이터(IPD) 계획
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