Stone, Kidney, Stone;Renal, Stones, Kidney
Conditions
Brief summary
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.
Interventions
PROCEDUREThe T-Tilt position
The 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.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Severe cardiovascular disease (e.g., heart failure) * Congenital kidney anomalies (e.g., horseshoe kidney, ectopic kidney) * Concurrent ureteral stones * Pregnancy or planning pregnancy * History of previous kidney surgery on the same side * Active urinary tract infection (UTI) * Coagulopathy or use of anticoagulant therapy that cannot be stopped before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate After Retrograde Intrarenal Surgery | 6 weeks post-surgery | The percentage of participants with no residual kidney stones (≤4 mm fragments) on non-contrast computed tomography (CT) at 6 weeks postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complication Rate | Within 30 days post-surgery | he percentage of participants experiencing any postoperative complications, classified according to the Clavien-Dindo grading system. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalization Rate | Within 30 days post-surgery | The percentage of participants requiring hospital readmission due to complications related to the surgical procedure |
| Total Laser Energy Used | Intraoperative | The total Holmium:YAG laser energy (Joules) applied during stone fragmentation |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMurat Gulsen
Outcome results
None listed