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

Официальное название

Does the Positioning in Retrograde Intrarenal Surgery Affect Stone-Free Rates? A Prospective Randomized Controlled Trial

Обзор

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.

Вмешательства

• Процедура 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 sto

Первичные конечные точки

• Stone-Free Rate After Retrograde Intrarenal Surgery [Срок оценки: 6 weeks post-surgery]

Вторичные конечные точки (1)

• Postoperative Complication Rate [Срок оценки: Within 30 days post-surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ondokuz Mayıs University — Samsun

Публикации

• 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
• 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

Идентификаторы

NCT: NCT06809582 · B.30.2.ODM.0.20.08/603-670

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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