CClinicalTrials.gg
RecruitingNCT06809582POS-RIRS-RCTUpdated Aug 15, 2025

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

An interventional study of The T-Tilt position in Stone, Kidney, Stones, Kidney and Stone;Renal, sponsored by Ondokuz Mayıs University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stone, Kidney
  • Stones, Kidney
  • Stone;Renal
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 128 is above the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • No intervention
    Standard lithotomy position

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

  • Active comparator
    T-Tilt Lithotomy Position

    Procedure: The T-Tilt position

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.

06

What researchers measure

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.

    Time frame: 6 weeks post-surgery

Secondary outcomes

  1. Postoperative Complication Rate

    he percentage of participants experiencing any postoperative complications, classified according to the Clavien-Dindo grading system.

    Time frame: Within 30 days post-surgery

Other outcomes

  1. Rehospitalization Rate

    The percentage of participants requiring hospital readmission due to complications related to the surgical procedure

    Time frame: Within 30 days post-surgery

  2. Total Laser Energy Used

    The total Holmium:YAG laser energy (Joules) applied during stone fragmentation

    Time frame: Intraoperative

07

Study locations

1 of 1 sites recruiting
  • Ondokuz Mayıs University
    Samsun, Turkey (Türkiye)
    Recruiting
08

References and documents

Publications

  • 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. PubMed 38722376 ↗
  • 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. PubMed 34251886 ↗

Study documents

  • Statistical analysis plan · Jan 29, 2025
  • Informed consent form · Nov 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06809582
Lead sponsor
Ondokuz Mayıs University
Responsible party
Murat Gulsen (Assistant professor, Ondokuz Mayıs University) — Principal investigator
First posted
Feb 5, 2025
Start date
Jan 1, 2025
Primary completion
Dec 1, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Aug 15, 2025

Study contacts

Murat Gulsen
Contact
mglotr@gmail.com
+905062357421
Murat Gulsen
principal investigator · Ondokuz Mayıs University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion