A Novel Technique in Tubeless Percutaneous Nephrolithotomy Using Nebulized Glubran 2 Versus Conventional Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
This prospective randomized controlled study will compare two techniques used after percutaneous nephrolithotomy, a procedure for removing kidney stones. Participants with renal stones measuring 2-3 cm will be randomly assigned to either tubeless percutaneous nephrolithotomy with nebulized Glubran 2 used to seal the access tract or conventional percutaneous nephrolithotomy with placement of a nephrostomy tube. The study will evaluate whether the Glubran 2-assisted tubeless technique is safe and effective and whether it can reduce postoperative pain, bleeding, hospital stay, urine leakage, and other complications while maintaining a satisfactory stone-free rate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Single or multiple renal stones measuring 2-3 cm.
- •Renal stones located in an anatomical position suitable for percutaneous nephrolithotomy.
- •Participant considered suitable for PCNL under general anesthesia.
- •Ability and willingness to provide written informed consent.
排除标准
- •Active urinary tract infection.
- •Renal stones in an anomalous kidney.
- •Uncontrolled hypertension.
- •Uncontrolled diabetes mellitus.
- •Uncorrected coagulopathy.
- •Clinically significant arrhythmia.
- •Distal ureteric obstruction.
- •Fixed hip joints preventing appropriate operative positioning.
- •Previous renal surgery.
- •Requirement for more than one percutaneous puncture.
- •Pelvicalyceal system perforation during the procedure.
- •Excessive intraoperative bleeding.
- •Any intraoperative finding requiring nephrostomy tube placement for safety.
研究组 & 干预措施
Nebulized Glubran 2-Assisted Tubeless PCNL
Participants will undergo percutaneous nephrolithotomy followed by tubeless closure of the percutaneous access tract. After stone removal and confirmation of no significant collecting-system injury, 1 mL of Glubran 2 will be delivered into the tract using a special nebulizing applicator under endoscopic and fluoroscopic guidance. The tract will be temporarily occluded using the balloon of a 16 Fr Foley catheter. No nephrostomy tube will be placed. A 6 Fr double-J ureteral stent may be inserted when clinically indicated.
干预措施: Nebulized Glubran 2-Assisted Tubeless PCNL (Procedure)
Conventional PCNL With Nephrostomy Tube
Participants will undergo conventional percutaneous nephrolithotomy. After stone removal, a 24 Fr Nelaton tube will be placed as a nephrostomy tube for postoperative drainage. The nephrostomy tube is planned to be removed after approximately 24 hours, according to the participant's clinical condition. A 6 Fr double-J ureteral stent may be inserted when clinically indicated.
干预措施: Conventional PCNL With Nephrostomy Tube (Procedure)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Within the first 24 hours after surgery
Postoperative pain will be assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be compared between the nebulized Glubran 2-assisted tubeless PCNL group and the conventional PCNL group.
次要结局
- Stone-Free Rate(At 24 hours after surgery)
- Postoperative Hemoglobin Change(From baseline before surgery to 24 hours after surgery)
- Blood Transfusion Requirement(From the end of surgery through 24 hours after surgery)
- Urinary Leakage(From the end of surgery through 48 hours after surgery)
- Length of Hospital Stay(From the end of surgery through 30 days after surgery)
- Intraoperative Blood Loss(Intraoperatively)
- Fluoroscopy Exposure Time(Intraoperatively)
研究者
Saad ali saad salama
Lecturer of Urology
Benha University