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This completed randomized clinical study was designed to compare three different techniques of retrograde intrarenal surgery (retrograde intrarenal surgery) for the treatment of kidney stones that are 2 centimeters or smaller. Retrograde intrarenal surgery is a minimally invasive procedure in which a flexible scope is passed through the urinary tract to reach the kidney and fragment the stone.
The clinical study included three groups of patients. The first group underwent retrograde intrarenal surgery using a traditional ureteral access sheath, which is a hollow tube placed in the ureter to facilitate the passage of instruments and help control pressure inside the kidney. The second group underwent retrograde intrarenal surgery using a suction ureteral access sheath, which combines the function of a traditional sheath with gentle suction to help remove stone fragments and reduce internal pressure. The third group underwent sheathless retrograde intrarenal surgery, in which the flexible surgical scope is inserted directly without the use of any ureteral access sheath.
The purpose of this clinical study was to determine whether these three approaches differ in terms of stone clearance, operative time, intraoperative complications such as bleeding or fluid leakage, and early postoperative complications such as fever or infection. All participants were adults with a single kidney stone between 1 and 2 centimeters, normal kidney function, and no active infection or anatomical abnormalities. All procedures were performed at Ain Shams University Hospitals using the same surgical equipment and technique to ensure comparability between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Ureteral Access Sheath Retrograde Intrarenal Surgery | Active Comparator | Participants in this arm underwent retrograde intrarenal surgery (retrograde intrarenal surgery) using a traditional ureteral access sheath. A flexible ureteroscope was advanced through an 11 French by 13 French ureteral access sheath positioned near the ureteropelvic junction. Irrigation was maintained at 50 to 100 milliliters per minute. Stone fragmentation was performed using a holmium:yttrium-aluminum-garnet laser device. All patients received a six French double-J stent at the end of the procedure. Intraoperative complications were recorded, and postoperative imaging was performed for outcome assessment. |
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| Suction Ureteral Access Sheath Retrograde Intrarenal Surgery | Experimental | Participants in this arm underwent retrograde intrarenal surgery (retrograde intrarenal surgery) with the use of a suction ureteral access sheath. An 11 French suction ureteral access sheath was inserted over a guidewire and positioned in the renal pelvis. The suction system was connected to a vacuum device, with negative pressure set between 2 and 7 kilopascals to facilitate evacuation of stone fragments and reduce intrarenal pressure. The same flexible ureteroscope and holmium:yttrium-aluminum-garnet laser lithotripsy technique were used as in the traditional arm. A six French double-J stent was inserted at the end of the operation. All intraoperative and postoperative findings were documented. |
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| Sheathless Retrograde Intrarenal Surgery | Experimental | Participants in this arm underwent sheathless retrograde intrarenal surgery (retrograde intrarenal surgery), in which the flexible ureteroscope was inserted directly over a guidewire without the placement of any ureteral access sheath. Stone fragmentation was performed using a holmium:yttrium-aluminum-garnet laser device. A six French double-J stent was placed at the end of the procedure. Any intraoperative complications, such as bleeding or extravasation, were documented, and postoperative imaging was conducted to assess stone clearance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional ureteral access sheath retrograde intrarenal surgery | Procedure | This intervention involves performing retrograde intrarenal surgery using a traditional ureteral access sheath to facilitate entry of the flexible ureteroscope and maintain controlled intrarenal pressure. The procedure includes endoscopic fragmentation of renal calculi using a holmium:yttrium-aluminum-garnet laser device and placement of a double-J ureteral stent at the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate assessed by non-contrast computed tomography of the urinary tract | Stone-free status is evaluated using non-contrast computed tomography of the urinary tract performed after surgery. Residual stone fragments are classified into four grades: Grade A, no stones detected (absolute stone-free); Grade B, residual fragments less than or equal to 2 millimeters (relative stone-free); Grade C, residual fragments 2.1 to 4 millimeters (relative stone-free); and Grade D, residual fragments greater than 4 millimeters (significant residual stones). The primary endpoint is the proportion of patients achieving stone-free status, defined as Grade A (absolute stone-free) and, in a secondary analysis, Grades A to C combined (clinically insignificant residual fragments). | One month after surgery (non-contrast computed tomography of the urinary tract performed approximately 30 days postoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time for retrograde intrarenal surgery | Operative time is measured in minutes from the insertion of the endoscopic instruments at the beginning of retrograde intrarenal surgery until completion of the procedure, including placement of the double-J ureteral stent. The metric is the mean operative time and distribution of operative time for each study arm. | During the surgical procedure on the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals - Department of Urology | Cairo | Cairo Governorate | 11511 | Egypt |
Individual participant data (IPD) that underlie the results of the completed clinical study will be made available to qualified researchers upon reasonable request. Shared data will include de-identified clinical information related to baseline characteristics, operative details, postoperative outcomes, and imaging-based assessments. No information that could directly identify a participant will be shared. Data will be provided for the purpose of scientific validation, secondary analysis, or meta-analysis.
De-identified individual participant data and supporting documents will become available beginning six months after publication of the study results and will remain available for a period of five years following that date.
Researchers wishing to access the de-identified dataset must submit a written request outlining their study objectives and analysis plan. Requests will be evaluated by the study investigators to ensure scientific validity and appropriate use of the data. Approved researchers will be required to sign a data use agreement stating that the information will be used solely for research purposes, will not be shared with unauthorized parties, and will not be used in any attempt to identify study participants.
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Participants were randomly assigned in a parallel fashion to one of three study arms: traditional ureteral access sheath retrograde intrarenal surgery (RIRS), suction ureteral access sheath retrograde intrarenal surgery (RIRS), or sheathless retrograde intrarenal surgery (RIRS). Each participant received only one of the three techniques, and the groups were followed and compared concurrently regarding stone clearance, operative time, intraoperative complications, and early postoperative complications.
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| Suction ureteral access sheath retrograde intrarenal surgery | Procedure | This intervention uses a suction ureteral access sheath that provides continuous negative pressure during retrograde intrarenal surgery. The system assists in evacuation of stone debris and helps control intrarenal pressure while the flexible ureteroscope and holmium:yttrium-aluminum-garnet laser device are used for stone fragmentation. A double-J ureteral stent is placed after the procedure. |
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| Sheathless retrograde intrarenal surgery | Procedure | This intervention involves performing retrograde intrarenal surgery without the use of any ureteral access sheath. The flexible ureteroscope is introduced directly over a guidewire to access the renal collecting system for laser fragmentation of the stone using a holmium:yttrium-aluminum-garnet laser device. A double-J ureteral stent is inserted following completion of the procedure. |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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