Impact of Surgical Position on Stone-Free Rates in Retrograde Intrarenal Surgery

NCT06809582 | Recruiting

• 1 other identifier: B.30.2.ODM.0.20.08/603-670
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Stone, Kidney; Stones, Kidney; Stone;Renal

Outcome Measures

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.

  6 weeks post-surgery

Secondary Outcomes (1)

• Postoperative Complication Rate

  Within 30 days post-surgery

Other Outcomes (2)

• Rehospitalization Rate

  Within 30 days post-surgery

• Total Laser Energy Used

  Intraoperative

Study Arms (2)

Standard lithotomy position

NO INTERVENTION

In this arm we will use standard lithotomy position as control group.

T-Tilt Lithotomy Position

ACTIVE COMPARATOR

Procedure: The T-Tilt position

Interventions

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.

T-Tilt Lithotomy Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 38722376 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.

  PMID: 34251886 RESULT

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Murat Gulsen

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Gulsen

CONTACT

+905062357421; mglotr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)