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

NCT ID: NCT06809582

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-06-01

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Stone, Kidney Stones, Kidney Stone;Renal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard lithotomy position

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

Group Type NO_INTERVENTION

No interventions assigned to this group

T-Tilt Lithotomy Position

Group Type ACTIVE_COMPARATOR

The T-Tilt position

Intervention Type 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.

Interventions

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The 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Murat Gulsen

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Gulsen

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

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Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Murat Gulsen

Role: CONTACT

+905062357421

Facility Contacts

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Murat Gulsen

Role: primary

+905062357421

References

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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.

Reference Type RESULT
PMID: 38722376 (View on PubMed)

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.

Reference Type RESULT
PMID: 34251886 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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B.30.2.ODM.0.20.08/603-670

Identifier Type: -

Identifier Source: org_study_id

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