Holmium LASER enbloc Transurethral Resection of Bladder Tumor (HoL-ERBT) Vs Conventional Transurethral Resection of Bladder Tumor (cTURBT) for primary bladder tumors: Randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of histopathological parameters (Deep Muscle Presence, Cautery Artefact) in HoL-ERBT and cTURBT
研究概览
简要总结
With the ubiquitous availability of Holmium LASER major centers started using holmium LASER as energy source for resection in ERBT (HoL-ERBT). The current available literature says that HoL-ERBT represents an improvement in the surgical management of bladder tumor. The resection is more precise and complete compared to cTURBT. However, the limitations were large tumors, difficult locations and methods of retrieval. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy. In comparison to cTURBT, HoL-ERBT has advantages in reducing irrigation time and avoiding bladder perforation, although it may require a longer operating time; no benefit in terms of recurrence rates has been demonstrated. However limited RCTs are available and inclusion criteria are narrow on this topic.
Our randomized controlled trial (RCT) aims to evaluate the feasibility, histopathological benefits, and clinical outcomes of HoL-ERBT compared to cTURBT. This study seeks to address existing gaps in research and provide valuable insights into the optimal surgical management of bladder tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients diagnosed with Bladder Mass
- •Size of tumour up to 4 cm
- •No invasion of adjacent organs
- •Up to 4 tumours in number.
排除标准
- •Not Fit for Surgery.
- •Patient refused to participate.
- •Tumor larger than 4 cm in size.
- •Tumors more than 4 in number.
结局指标
主要结局
Comparison of histopathological parameters (Deep Muscle Presence, Cautery Artefact) in HoL-ERBT and cTURBT
时间窗: 14 days, 6 weeks, 6 months
次要结局
- 1. To assess efficiency of HoL-ERBT vs cTURBT in terms of complete resection of tumor.(2. Compare peri-operative complications.)
研究者
Dr Aquib Javed Mubarak Ali Patel
AIIMS JODHPUR
