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临床试验/NCT06796413
NCT06796413已完成不适用

Loop Resection or Cold-cup Biopsy? a Prospective Randomized Study Evaluating the Accuracy of Detrusor Muscle Representation During Transurethral Resection of Bladder Tumors

University of Stellenbosch1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Detrusor Muscle Representation

研究概览

简要总结

In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. The investigators found that both sampling methods are equal effective with regards to muscle representation, regardless of surgeon experience. An important finding is that Loop Resection produced less tissue artefacts in the deep muscle specimen for the more experienced surgeons, while there was no difference for less experienced surgeons. The investigators thus conclude that - from a practical point of view - Loop Resection should be the deep muscle sampling method of choice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •• All patients requiring cystoscopy plus loop resection of bladder tumor.

排除标准

  • •• Patients who underwent cystoscopy and no loop resection
  • •Patients who underwent cystoscopy and only cold-cup biopsy

研究组 & 干预措施

Cold-Cup Biopsy

Active Comparator

Cold-Cup Biopsy of bladder tumor base

干预措施: Loop Resection or Cold-cup biopsy (Procedure)

Loop Resection of bladder tumor base

Experimental

Loop Resection of bladder tumor base

干预措施: Loop Resection or Cold-cup biopsy (Procedure)

结局指标

主要结局

Detrusor Muscle Representation

时间窗: From enrollment to the end of treatment at 2-4 weeks when histology results are available

Histopathological confirmation of detrusor muscle representation in the Deep Muscle Specimen obtained by either the Loop Resection method or Cold-Cup Biopsy method

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Eduan Delport

Urology Resident

University of Stellenbosch

研究点 (1)

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