Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery
The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery
This prospective, randomized, comparative study aims to evaluate the impact of aspirating and non-aspirating ureteral access sheaths on success rates and complications in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. A total of 70 patients with renal stones smaller than 2 cm will be enrolled and randomly assigned to two groups. One group will undergo RIRS using a non-aspirating ureteral access sheath, while the other group will be treated using an aspirating ureteral access sheath.
The primary outcome of the study is the stone-free rate, which will be assessed at postoperative follow-up. Secondary outcomes include operative time, fluoroscopy time, length of hospital stay, postoperative complications according to the Clavien-Dindo classification, infection-related parameters, and the need for ureteral stenting.
The study aims to determine whether the use of an aspirating access sheath improves surgical outcomes by reducing intrarenal pressure, enhancing visualization, and decreasing complication rates. The findings are expected to contribute to optimizing device selection and improving clinical outcomes in endoscopic kidney stone surgery.
調査の概要
状態
条件
詳細な説明
This study is designed as a prospective, randomized, comparative clinical trial to evaluate the effectiveness and safety of aspirating versus non-aspirating ureteral access sheaths in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones.
Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the collecting system, maintain low intrarenal pressure, and improve visualization. While conventional non-aspirating sheaths allow passive outflow of irrigation fluid, aspirating sheaths provide active suction, which may enhance fragment evacuation, reduce intrarenal pressure, and potentially decrease infectious complications. However, comparative clinical data between these two approaches remain limited.
In this study, a total of 70 patients aged 18 to 75 years with renal stones smaller than 2 cm will be enrolled after providing informed consent. Patients will be randomized into two groups using a computer-generated block randomization method. The first group will undergo RIRS using a non-aspirating ureteral access sheath, while the second group will undergo RIRS using an aspirating ureteral access sheath. All procedures will be performed using a standardized surgical technique.
Demographic characteristics, stone-related parameters, and perioperative variables will be recorded. Postoperative follow-up will include clinical and radiological evaluation. Stone-free status will be assessed during postoperative follow-up. Complications will be classified according to the Clavien-Dindo classification. Additional parameters, including operative time, fluoroscopy time, length of hospital stay, infection-related laboratory findings, and the need for auxiliary procedures, will also be evaluated.
The aim of this study is to determine whether the use of an aspirating ureteral access sheath improves surgical efficiency and safety compared with a conventional sheath. The results are expected to provide evidence to guide clinical decision-making in endoscopic kidney stone surgery.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：AHMET TAŞCI
- 電話番号：+905531596690
- メール：ahmettasci400@gmail.com
研究場所
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Çorum
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Çorum、Çorum、トルコ（Türkiye）、19040
- 募集
- Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
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コンタクト：
- AHMET TAŞCI
- 電話番号：+90 553 159 6690
- メール：ahmettasci400@gmail.com
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主任研究者：
- AHMET TAŞCI
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副調査官：
- MUSA EKİCİ
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients aged between 18 and 75 years
- Patients diagnosed with kidney stones smaller than 2 cm
- Patients scheduled for retrograde intrarenal surgery (RIRS)
- Patients who provide written informed consent
Exclusion Criteria:
- Patients with active urinary tract infection
- Patients with coagulopathy
- Pregnant patients
- Patients unable to tolerate the lithotomy position
- Patients with incomplete clinical or laboratory data
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Non-aspirating ureteral access sheath
Patients undergoing retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath.
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A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
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実験的：Aspirating ureteral access sheath
Patients undergoing retrograde intrarenal surgery (RIRS) using an aspirating ureteral access sheath.
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A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Stone-free status
時間枠：At 3 weeks postoperatively
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Stone-free status is defined as the absence of residual stones on low-dose non-contrast computed tomography or plain urinary system radiography at 3 weeks postoperatively.
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At 3 weeks postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Operation time
時間枠：Measured during surgery, from incision to closure (intraoperative period)
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Operative time is defined as the duration from the start of the operation to its completion.
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Measured during surgery, from incision to closure (intraoperative period)
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Length of hospital stay
時間枠：From postoperative admission to hospital discharge, assessed up to 30 days
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Length of hospital stay is defined as the time from postoperative hospital admission to hospital discharge, measured in days.
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From postoperative admission to hospital discharge, assessed up to 30 days
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Intraoperative complications
時間枠：From start to completion of surgery (intraoperative period)
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Intraoperative complications are defined as any adverse events occurring during the surgical procedure, including but not limited to bleeding, ureteral injury, or technical difficulties.
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From start to completion of surgery (intraoperative period)
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Postoperative infectious complications
時間枠：From end of surgery to 7 days postoperatively
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Postoperative infectious complications are defined as infection-related adverse events occurring after surgery, including fever, urinary tract infection, and sepsis.
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From end of surgery to 7 days postoperatively
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.
- Kwok JL, Somani B, Sarica K, Yuen SKK, Zawadzki M, Castellani D, Persaud S, Chai CA, Kamal W, Tefik T, Tursunkulov AN, Soebhali B, Hajj AE, Ko R, Fong KY, Dragos L, Tanidir Y, Angerri O, Traxer O, Gauhar V. Multicenter outcome analysis of different sheath sizes for Flexible and Navigable Suction ureteral access sheath (FANS) ureteroscopy: an EAU Endourology collaboration with the global FANS study group. Urolithiasis. 2024 Nov 15;52(1):162. doi: 10.1007/s00240-024-01662-4.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ETIK-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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