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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:
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:
This study aims to improve surgical techniques and patient outcomes in kidney stone treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard lithotomy position | No Intervention | In this arm we will use standard lithotomy position as control group. | |
| T-Tilt Lithotomy Position | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The T-Tilt position | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complication Rate | he percentage of participants experiencing any postoperative complications, classified according to the Clavien-Dindo grading system. | Within 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization Rate | The percentage of participants requiring hospital readmission due to complications related to the surgical procedure | Within 30 days post-surgery |
| Total Laser Energy Used | The total Holmium:YAG laser energy (Joules) applied during stone fragmentation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murat Gulsen | Contact | +905062357421 | mglotr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Murat Gulsen | Ondokuz Mayıs University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs University | Recruiting | Samsun | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38722376 | Result | Canakci C, Dincer E, Can U, Coskun A, Otbasan BK, Ozkaptan O. The relationship between stone-free and patient position in retrograde intrarenal surgery: a randomized prospective study. World J Urol. 2024 May 9;42(1):308. doi: 10.1007/s00345-024-05013-1. | |
| 34251886 | Result | Liaw CW, Khusid JA, Gallante B, Bamberger JN, Atallah WM, Gupta M. The T-Tilt Position: A Novel Modified Patient Position to Improve Stone-Free Rates in Retrograde Intrarenal Surgery. J Urol. 2021 Nov;206(5):1232-1239. doi: 10.1097/JU.0000000000001948. Epub 2021 Jul 12. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2025 | Jan 30, 2025 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2024 | Jan 30, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Intraoperative |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |