Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAntalya Health Sciences University
About this trial
The goal of this observational study is to compare conventional and suction (aspiration) ureteral access sheaths used during retrograde intrarenal surgery (RIRS) in adults with kidney stones.
The main questions it aims to answer are:
* Does the use of a suction ureteral access sheath increase the stone-free rate compared with a conventional sheath? * Does the use of a suction sheath reduce operative time and complications such as postoperative fever and infection?
Researchers will compare patients treated with a conventional ureteral access sheath with patients treated with a suction ureteral access sheath during routine RIRS.
Participants will:
* Undergo RIRS for kidney stones as part of their routine clinical care * Have their surgical data recorded, including operative time and any complications * Attend routine follow-up visits, including imaging to assess whether stones remain
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Kidney stones scheduled for retrograde intrarenal surgery (RIRS)
Provision of written informed consent
Disqualifiers
Active untreated urinary tract infection
Uncorrected bleeding disorder or anticoagulant therapy that cannot be discontinued
Pregnancy
Anatomical abnormalities of the urinary tract (e.g., ureteral stricture, horseshoe kidney)
Trial population
Adult patients with kidney stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) with either a conventional or a suction ureteral access sheath at the Department of Urology, University of Health Sciences Antalya Training and Research Hospital, Antalya, Turkey.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Conventional Ureteral Access Sheath
DeviceA standard CE-marked ureteral access sheath without suction, placed during RIRS to provide repeated access to the kidney and facilitate irrigation outflow.
Suction Ureteral Access Sheath
DeviceA CE-marked ureteral access sheath connected to a negative-pressure suction system, placed during RIRS to allow continuous aspiration of irrigation fluid and stone fragments.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Conventional Ureteral Access Sheath Group1 intervention
Group B: Suction Ureteral Access Sheath Group1 intervention
Trial outcomes
Primary outcomes
1
Stone-Free Rate
Proportion of patients who are stone-free, defined as no residual stone fragments or residual fragments smaller than 4 mm. Stone-free status will be assessed by non-contrast computed tomography (NCCT) or, for radiopaque stones, by plain kidney-ureter-bladder (KUB) radiography.
Time frame
1 month after surgerySecondary outcomes
1
Postoperative Fever and Infectious Complications
Proportion of patients who develop postoperative fever (body temperature ≥38°C), urinary tract infection, or sepsis.
Time frame
Within 7 days after surgery2
Operative Time
Total duration of surgery, measured in minutes from insertion of the ureteroscope to placement of the ureteral stent or end of the procedure
Time frame
During surgery3
Postoperative Complications
Proportion of patients with postoperative complications, graded according to the Clavien-Dindo classification.
Time frame
Within 30 days after surgery4
Total Laser Energy
Total laser energy delivered during lithotripsy, measured in kilojoules (kJ) as recorded by the laser device.
Time frame
During surgerySponsors and contacts
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Source ClinicalTrials.gov