Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

Official title

The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery

Overview

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

• Device Non-aspirating ureteral access sheath
  A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
• Device Aspirating ureteral access sheath
  A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.

Primary outcome measures

• Stone-free status [Time frame: At 3 weeks postoperatively]

Secondary outcome measures (4)

• Operation time [Time frame: Measured during surgery, from incision to closure (intraoperative period)]
• Length of hospital stay [Time frame: From postoperative admission to hospital discharge, assessed up to 30 days]
• Intraoperative complications [Time frame: From start to completion of surgery (intraoperative period)]
• Postoperative infectious complications [Time frame: From end of surgery to 7 days postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Ç — Çorum

Publications

• Kwok JL, Somani B, Sarica K, Yuen SKK, Zawadzki M, Castellani D, Persaud S, Chai CA, Kamal W, Tefik T, Tursunkulov AN, Soebhali B, Hajj AE, Ko R, Fong KY, Dragos L, Tanidir Y, Angerri O, Traxer O, Gauhar V. Multicenter outcome analysis of different sheath sizes for Flexible and Navigable Suction ureteral access sheath (FANS) ureteroscopy: an EAU Endourology collaboration with the global FANS study PMID 39545972
• Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access She PMID 38789313

Identifiers

NCT: NCT07568990 · ETIK-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗