Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery
ConditionKidney Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHitit University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with active urinary tract infection
Patients with coagulopathy
Pregnant patients
Patients unable to tolerate the lithotomy position
Trial design
Design model
Parallel
Treatments tested in this trial
Non-aspirating ureteral access sheath
DeviceA conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
Aspirating ureteral access sheath
DeviceA ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Non-aspirating ureteral access sheathExperimental treatment 1 intervention
Group B: Aspirating ureteral access sheathExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stone-free status
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.
Time frame
At 3 weeks postoperativelySecondary outcomes
1
Operation time
Operative time is defined as the duration from the start of the operation to its completion.
Time frame
Measured during surgery, from incision to closure (intraoperative period)2
Length of hospital stay
Length of hospital stay is defined as the time from postoperative hospital admission to hospital discharge, measured in days.
Time frame
From postoperative admission to hospital discharge, assessed up to 30 days3
Intraoperative complications
Intraoperative complications are defined as any adverse events occurring during the surgical procedure, including but not limited to bleeding, ureteral injury, or technical difficulties.
Time frame
From start to completion of surgery (intraoperative period)4
Postoperative infectious complications
Postoperative infectious complications are defined as infection-related adverse events occurring after surgery, including fever, urinary tract infection, and sepsis.
Time frame
From end of surgery to 7 days postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov