Safety and Efficacy of Bipolar vs Monopolar Transurethral Resection of Bladder Tumor-A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- obturator jerk occurrence
研究概览
简要总结
Study design:
This was a single center, parallel arm, randomized, controlled trial done at Tribhuvan University Teaching Hospital,Institute Of Medicine from May 2017 to April 2018. The allocation ratio was 1:1.
Inclusion criteria: All patients undergoing Transurethral Resection of Bladder Tumor for suspected bladder tumors.
Exclusion criteria were: Consent withdrawal, bladder tumour other than in the lateral wall, unfit for spinal anesthesia and need of general anesthesia or obturator nerve block.
Methodology:
All patients suspected to have bladder cancer were subjected to imaging or cystoscopy and with confirmation of the diagnosis; they were randomized into two arms of TURBT. Spinal anesthesia was used in all cases. To overcome the potential confounding effect on our primary end point, obturator jerk, nerve block was not used.
Cystoscopy was done first and the findings were noted before proceeding to TURBT.
Tumors were resected in block from periphery to center with the stalk resected last. An additional sample of deep muscle was obtained from the tumor base and sent for histopathological examination in different containers.
All study variables were recorded in Per forma during the operation and in post operative period. Hemoglobin and sodium level was determined in immediate post operative period.
Postoperative irrigation was done with normal saline in both the resection groups and continued till the urine was clear. The catheter was removed after 48 hours in uncomplicated cases and patients were discharged. Patients were followed up in OPD at 2 weeks with the
详细描述
All patients suspected to have bladder cancer were subjected to imaging or cystoscopy and with confirmation of the diagnosis; they were randomized into two arms of TURBT. Spinal anesthesia was used in all cases.
To overcome the potential confounding effect on our primary end point, obturator jerk, nerve block was not used.
Cystoscopy was done first and the findings were noted before proceeding to TURBT.
Monopolar resection was done using 1.5% Glycine solution at 110 watt cutting, and 70 watt coagulation power (Covidien Valley-lab Force Fx TM) with Karl Storz 26f resectoscope and loop (8mm width and 5mm depth) with 300 telescope. Bipolar resection was done with 0.9% Normal Saline with digital impedence dependent cutting (power range 150-250 watt) and 80 watt coagulation power (Bowa Arc 400) with Karl Storz 26f resectoscope and loop (6mm width and 5mm depth) with 300 telescope.
Tumors were resected in block from periphery to center with the stalk resected last. An additional sample of deep muscle was obtained from the tumor base and sent for histopathological examination in different containers. All study variables were recorded in Per forma during the operation and in post operative period. Hemoglobin and sodium level was determined in immediate post operative period.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing TURBT for suspected bladder tumors.
排除标准
- •Consent withdrawal, bladder tumour other than in the lateral wall, unfit for spinal anesthesia and need of general anesthesia or obturator nerve block.
结局指标
主要结局
obturator jerk occurrence
时间窗: during TURBT
occurrence of obturator jerk (yes/no) will be recorded
次要结局
- time of resection (minutes(during TURBT)
- serum sodium(meq/l)(immediate post operative period)
- need for blood transfusion (yes/no)(immediate post operative period)
- clot retention (yes/no)(immediate post operative period)
- bladder perforation(yes/no)(during TURBT)
- TUR syndrome (yes/no)(during and after operation)
- decrease in hemoglobin (mg/dl)(immediate post operative period)
- presence of deep muscle (yes/no)(two weeks after operation ( as per usual availability of histopathology report in the hospital))
- severy cautery artifact(yes/no)(two weeks after operation ( as per usual availability of histopathology report in the hospital))
研究者
Manish Pradhan
Urology Lectuerer
Tribhuvan University, Nepal