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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative flank pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This is a single-blind study in which participants are unaware of their group assignment. Additionally, to ensure objective evaluation, the clinical staff (nurses) in the recovery room (PACU) who measure and record the primary outcome (NRS pain score) are blinded to the participants' treatment groups.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control group
Standard RIRS procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without additional active suctioning.
干预措施: Standard RIRS with natural drainage (Procedure)
Suction-induced collapse group
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.
干预措施: Complete suction-induced collapse (Procedure)
结局指标
主要结局
Postoperative flank pain intensity
时间窗: Within 1 hour after arrival in the post-anesthesia care unit (PACU)
Pain is assessed using an 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain.
次要结局
- Postoperative pain intensity as measured by the Numerical Rating Scale (NRS)(24 ± 4 hours after surgery)
- Incidence of infectious complications(Within 7 days after surgery)
研究者
Han Kyu Chae
Clinical associate professor
Kangdong Sacred Heart Hospital