Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNamik Kemal University
About this trial
This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age
Patients below 85 years of age
Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery
Disqualifiers
Patients with non-sterile preoperative urine culture
Patients with renal anatomic anomalies
Patients with a solitary (single) kidney
Patients with insufficient data
Trial design
Design model
Parallel
Treatments tested in this trial
Retrograde intrarenal surgery
Procedure/SurgeryFlexible optic devices and lasers fragment kidney stones during this operation. In this surgery, an ureteral access sheath is recommended to be used.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Patients with conventional UAS being used in their RIRS operationsActive comparator 1 intervention
Group B: Patients with vacuum assisted UAS being used in their RIRS operationsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stone free rates
Presence/absence of residual fragments in postoperative imaging, if any, diameter of longest axis in mm.
Time frame
Stone-free status will be checked by performing a non-contrast abdominal CT scan 1 month after the operation.Secondary outcomes
1
Complication rates
Peroperative and postoperative complication rates, whether UAS related or not
Time frame
Peroperative complication rates will be determined during the operation, and postoperative complications will be re-evaluated during hospitalization before discharge or in the first month after discharge.Sponsors and contacts
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Source ClinicalTrials.gov