Clinical trial NCT06809582: Impact of Surgical Position on Stone-Free Rates in Retrograde Intrarenal Surgery
Official title: Does the Positioning in Retrograde Intrarenal Surgery Affect Stone-Free Rates? A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stone, Kidney
Stones, Kidney
Stone;Renal
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stone-Free Rate After Retrograde Intrarenal Surgery
timeFrame: 6 weeks post-surgery
Secondary outcomes:
measure: Postoperative Complication Rate
timeFrame: Within 30 days post-surgery
Other outcomes:
measure: Rehospitalization Rate
timeFrame: Within 30 days post-surgery
measure: Total Laser Energy Used
timeFrame: Intraoperative
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Murat Gulsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.