Kidney Stones
Conditions
Keywords
retrograd intrarenal surgery, kidney stone, kidney
Brief summary
This prospective, randomized, comparative study aims to evaluate the impact of aspirating and non-aspirating ureteral access sheaths on success rates and complications in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. A total of 70 patients with renal stones smaller than 2 cm will be enrolled and randomly assigned to two groups. One group will undergo RIRS using a non-aspirating ureteral access sheath, while the other group will be treated using an aspirating ureteral access sheath. The primary outcome of the study is the stone-free rate, which will be assessed at postoperative follow-up. Secondary outcomes include operative time, fluoroscopy time, length of hospital stay, postoperative complications according to the Clavien-Dindo classification, infection-related parameters, and the need for ureteral stenting. The study aims to determine whether the use of an aspirating access sheath improves surgical outcomes by reducing intrarenal pressure, enhancing visualization, and decreasing complication rates. The findings are expected to contribute to optimizing device selection and improving clinical outcomes in endoscopic kidney stone surgery.
Detailed description
This study is designed as a prospective, randomized, comparative clinical trial to evaluate the effectiveness and safety of aspirating versus non-aspirating ureteral access sheaths in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the collecting system, maintain low intrarenal pressure, and improve visualization. While conventional non-aspirating sheaths allow passive outflow of irrigation fluid, aspirating sheaths provide active suction, which may enhance fragment evacuation, reduce intrarenal pressure, and potentially decrease infectious complications. However, comparative clinical data between these two approaches remain limited. In this study, a total of 70 patients aged 18 to 75 years with renal stones smaller than 2 cm will be enrolled after providing informed consent. Patients will be randomized into two groups using a computer-generated block randomization method. The first group will undergo RIRS using a non-aspirating ureteral access sheath, while the second group will undergo RIRS using an aspirating ureteral access sheath. All procedures will be performed using a standardized surgical technique. Demographic characteristics, stone-related parameters, and perioperative variables will be recorded. Postoperative follow-up will include clinical and radiological evaluation. Stone-free status will be assessed during postoperative follow-up. Complications will be classified according to the Clavien-Dindo classification. Additional parameters, including operative time, fluoroscopy time, length of hospital stay, infection-related laboratory findings, and the need for auxiliary procedures, will also be evaluated. The aim of this study is to determine whether the use of an aspirating ureteral access sheath improves surgical efficiency and safety compared with a conventional sheath. The results are expected to provide evidence to guide clinical decision-making in endoscopic kidney stone surgery.
Interventions
DEVICENon-aspirating ureteral access sheath
A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
DEVICEAspirating ureteral access sheath
A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.
Sponsors
Hitit University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned into two parallel groups using a computer-based block randomization method. One group will undergo retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath, while the other group will undergo RIRS using an aspirating ureteral access sheath.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 75 years * Patients diagnosed with kidney stones smaller than 2 cm * Patients scheduled for retrograde intrarenal surgery (RIRS) * Patients who provide written informed consent
Exclusion criteria
* Patients with active urinary tract infection * Patients with coagulopathy * Pregnant patients * Patients unable to tolerate the lithotomy position * Patients with incomplete clinical or laboratory data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free status | At 3 weeks postoperatively | Stone-free status is defined as the absence of residual stones on low-dose non-contrast computed tomography or plain urinary system radiography at 3 weeks postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Measured during surgery, from incision to closure (intraoperative period) | Operative time is defined as the duration from the start of the operation to its completion. |
| Length of hospital stay | From postoperative admission to hospital discharge, assessed up to 30 days | Length of hospital stay is defined as the time from postoperative hospital admission to hospital discharge, measured in days. |
| Intraoperative complications | From start to completion of surgery (intraoperative period) | Intraoperative complications are defined as any adverse events occurring during the surgical procedure, including but not limited to bleeding, ureteral injury, or technical difficulties. |
| Postoperative infectious complications | From end of surgery to 7 days postoperatively | Postoperative infectious complications are defined as infection-related adverse events occurring after surgery, including fever, urinary tract infection, and sepsis. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAHMET TAŞCI
Outcome results
None listed