Impact of Surgical Position on Stone-Free Rates in Retrograde Intrarenal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOndokuz Mayıs University
About this trial
The goal of this clinical trial is to determine whether the surgical position during retrograde intrarenal surgery (RIRS) affects stone-free rates in adults with kidney stones. The main questions it aims to answer are:
* Does the modified lithotomy position result in a higher stone-free rate compared to the standard lithotomy position? * Are there differences in complication rates between the two surgical positions?
Researchers will compare patients undergoing RIRS in the standard lithotomy position to those in the modified lithotomy position (30-degree Trendelenburg with elevated surgical side) to assess its impact on stone clearance and surgical outcomes.
Participants will:
* Be randomly assigned to one of two surgical positions * Undergo RIRS with standard surgical procedures * Have follow-up imaging to assess stone clearance after surgery
This study aims to improve surgical techniques and patient outcomes in kidney stone treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of single or multiple kidney stones, with the largest stone ≤2 cm
Age ≥18 years
Provided written informed consent to participate in the study
Indicated for retrograde intrarenal surgery (RIRS) as a treatment approach
Disqualifiers
Severe cardiovascular disease (e.g., heart failure)
Congenital kidney anomalies (e.g., horseshoe kidney, ectopic kidney)
Concurrent ureteral stones
Pregnancy or planning pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
The T-Tilt position
Procedure/SurgeryThe T-Tilt position is a modified lithotomy position used during retrograde intrarenal surgery (RIRS). In this position: The patient is placed in a 30-degree Trendelenburg position, meaning the head is slightly lower than the feet. The surgical side is elevated at a 30-degree angle to improve access to the kidney. This modified positioning is designed to enhance stone clearance, particularly by facilitating the movement of stone fragments away from the lower kidney calyces, where residual stones often remain. Researchers will compare this position to the standard lithotomy position to determine its impact on stone-free rates and surgical outcomes.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Standard lithotomy positionNo intervention 0 interventions
Group B: T-Tilt Lithotomy PositionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stone-Free Rate After Retrograde Intrarenal Surgery
The percentage of participants with no residual kidney stones (≤4 mm fragments) on non-contrast computed tomography (CT) at 6 weeks postoperatively.
Time frame
6 weeks post-surgerySecondary outcomes
1
Postoperative Complication Rate
he percentage of participants experiencing any postoperative complications, classified according to the Clavien-Dindo grading system.
Time frame
Within 30 days post-surgeryOther outcomes
1
Rehospitalization Rate
The percentage of participants requiring hospital readmission due to complications related to the surgical procedure
Time frame
Within 30 days post-surgery2
Total Laser Energy Used
The total Holmium:YAG laser energy (Joules) applied during stone fragmentation
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov