A study of efficacy of Thulium fiber laser vs holmium laser for stone lithotripsy during mini-Percutaneous Nephrolithotomy: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To evaluate safety of thulium fiber laser (TFL) and holmium laser for lithotripsy in the miniaturized percutaneous nephrolithotomy (Mini PCNL) for renal stones less than 3cms in terms of stone clearance and complications
研究概览
简要总结
Outcome : To evaluate the effectiveness and safety of thulium fiber laser (TFL) with holmium laser lithotripsy in the miniaturized percutaneous nephrolithotomy (Mini PCNL) for renal stones ≤ 3cms.
The present study will be conducted prospectively in KMCH, Manipal, MAHE, in the Department of Urology. A total of 128 patients will be included, who have renal stones ≤3 cm by CT scan. The type of stone was categorized according to Guy’s stone score. Stone volume was calculated in cubic millimeters by the computed tomography scan software. For multiple stones, all individual stone volumes were added up.
Mini PCNL will be performed by the standard method. All the procedures will be done under general anesthesia, in prone position and the puncture by the standard bullseye technique under fluoroscopy guidance and the tract dilatation upto 15-18Fr. The stone will be fragmented using either Ho: YAG or TFL.
Randomization will be done using online research randomizer tool (https://www.randomizer.org/). The patients will be assigned to each of the two treatment groups (group I and II). Group I is of patients who will undergo Mini PCNL with stone lithotripsy using Ho: YAG laser and Group II is of patients who will undergo Mini PCNL with stone lithotripsy using a TFL.
Ho: YAG laser lithotripsy by a 35-watt machine (Auriga XL 30W, Quanta Systems, Italy). For Ho: YAG laser, the settings range from 0.8–1.2 J energy to 10–15 Hz of frequency. The power levels ranged from 8 to 18 watts.
TFL lithotripsy by a 60-watt machine (Urolase SP, IPG Photonics, Russia). The TFL settings range from 0.5 to 1.5 J and 6–15 Hz; total power ranged from 6 to 15 watts.
Both lasers will be used with fixed energy settings of 10 watts.
The Lasing time will be noted for TFL and Ho: YAG laser. At the end of the procedure, stone clearance will be confirmed nephroscopically and fluoroscopically. The operative time for both the procedures will be noted.
The Lasing time will be assessed for both groups. The Lasing time is calculated from the start of laser energy on the stone and till the complete stone was disintegrated.
Postoperative care:
On follow-up, NCCT KUB will be done after 4 weeks to confirm stone-free status. Residual fragments ≥ 4 mm was considered as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are undergoing PCNL with stone size ≤ 3cm & who are consenting for the study at the Department of Urology, kasturba Hospital, Manipal.
排除标准
- •Patients opting RIRS, ESWL, Stone size more than three cms and having contra-indications for PCNL like Pregnancy, Infected HUN, Uncorrected Coagulopathy and patients not willing to participate in study.
结局指标
主要结局
To evaluate safety of thulium fiber laser (TFL) and holmium laser for lithotripsy in the miniaturized percutaneous nephrolithotomy (Mini PCNL) for renal stones less than 3cms in terms of stone clearance and complications
时间窗: 0 - at surgery and 1 month
次要结局
未报告次要终点
研究者
Venkata Srinadh Gaddam
Kasturba hospital, manipal