Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of RIRS on Early Postoperative Outcomes

Официальное название

Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of Retrograde Intrarenal Surgery on Early Postoperative Outcomes: A Prospective Randomized Study

Обзор

The purpose of this study is to evaluate whether actively suctioning the renal collecting system to induce a "collapse" state at the end of retrograde intrarenal surgery (RIRS) can reduce postoperative pain and infection in patients with kidney stones. Participants will be randomly assigned to either the experimental group (suction-induced collapse) or the control group (standard drainage). The study aims to determine if this simple surgical modification can improve early recovery outcomes and patient satisfaction.

Подробное описание

While RIRS is a standard treatment for kidney stones, postoperative flank pain and infectious complications remain significant issues. These complications are often associated with elevated intrarenal pressure and residual irrigation fluid left in the kidney after surgery.

This prospective randomized controlled trial investigates the clinical efficacy of a "suction-induced collapse" technique using a suction ureteral access sheath (UAS). In the experimental group, at the conclusion of RIRS, active suction will be applied through the UAS until the renal collecting system is visually confirmed to be collapsed. In the control group, standard drainage will be allowed after irrigation stops, without active suctioning.

The primary outcome is postoperative flank pain intensity measured by the Numerical Rating Scale (NRS) in the recovery room. Secondary outcomes include pain scores on postoperative day 1, the incidence of infectious complications (fever, UTI, or sepsis) within 7 days, and the total amount of analgesics used. A total of 90 patients will be enrolled to ensure statistical power.

Вмешательства

• Процедура Complete suction-induced collapse
  At the end of Retrograde Intrarenal Surgery (RIRS), active suctioning is performed through a suction ureteral access sheath (UAS) until the renal collecting system is visually confirmed to be collapsed.
• Процедура Standard RIRS with natural drainage
  Standard Retrograde Intrarenal Surgery (RIRS) procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without any additional active suctioning.

Первичные конечные точки

• Postoperative flank pain intensity [Срок оценки: Within 1 hour after arrival in the post-anesthesia care unit (PACU)]

Вторичные конечные точки (2)

• Postoperative pain intensity as measured by the Numerical Rating Scale (NRS) [Срок оценки: 24 ± 4 hours after surgery]
• Incidence of infectious complications [Срок оценки: Within 7 days after surgery]

Критерии участия

Критерии включения

• Patients aged 20 to 80 years.
• Patients diagnosed with kidney stones and scheduled for retrograde intrarenal surgery (RIRS).
• Patients who have voluntarily signed the written informed consent form

Критерии исключения

• Participation in another clinical trial (drug or device) within 1 month prior to enrollment.
• Congenital abnormalities of the urinary or reproductive system.
• Presence of a pre-placed ureteral stent (pre-stenting) at the time of surgery.
• Solitary kidney.
• Uncontrolled urinary tract infection.
• History of ureteral reconstruction on the affected side.
• Pregnancy.
• Uncorrectable bleeding diathesis or ongoing therapeutic anticoagulation therapy.
• Contraindications to general anesthesia.
• Other conditions that the investigator deems inappropriate for participation in the study.

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

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Kangdong Sacred Heart Hospital — Gandong-gu

Публикации

• Tzelves L, Geraghty R, Juliebo-Jones P, Yuan Y, Kapriniotis K, Castellani D, Gauhar V, Skolarikos A, Somani B. Suction use in ureterorenoscopy: A systematic review and meta-analysis of comparative studies. BJUI Compass. 2024 Jul 8;5(10):895-912. doi: 10.1002/bco2.408. eCollection 2024 Oct. PMID 39416755
• Rogers AC, Van De Hoef D, Sahebally SM, Winter DC. A meta-analysis of carbon dioxide versus room air insufflation on patient comfort and key performance indicators at colonoscopy. Int J Colorectal Dis. 2020 Mar;35(3):455-464. doi: 10.1007/s00384-019-03470-4. Epub 2020 Jan 3. PMID 31900583
• Khusid JA, Hordines JC, Sadiq AS, Atallah WM, Gupta M. Prevention and Management of Infectious Complications of Retrograde Intrarenal Surgery. Front Surg. 2021 Aug 9;8:718583. doi: 10.3389/fsurg.2021.718583. eCollection 2021. PMID 34434958
• Zhang H, Jiang T, Gao R, Chen Q, Chen W, Liu C, Mao H. Risk factors of infectious complications after retrograde intrarenal surgery: a retrospective clinical analysis. J Int Med Res. 2020 Sep;48(9):300060520956833. doi: 10.1177/0300060520956833. PMID 32993406

Идентификаторы

NCT: NCT07535281 · 2025-08-010-001 · 2025-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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