跳至主要内容
临床试验/CTRI/2023/03/050494
CTRI/2023/03/050494尚未招募Phase 3 4

A randomised controlled trial comparing infectious complications using mini perc with and without suction for renal stones less than 3 cm in size

Muljibhai Patel Urological Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月3日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Post procedure Infection (fever, sepsis)

研究概览

简要总结

Tract size between 14-22 Fr is called as mini-PCNL. This was first introduced in the year 2001 and since then various modifications have been made to the equipment.

Miniaturization of PCNL sheath decreases morbidity to the patient. There is a decrease in blood loss with maintained stone-free rates along with a lesser need for blood transfusion. There is greater manoeuvrability of the miniaturised sheath in the pelvicalyceal system as well as less requirement of placement of nephrostomy tube in mini-PCNL. There is an additional benefit that the smaller dust particles are also extracted leaving behind little chance of a residual fragments.

The use of suction sheath in Mini-PCNL was introduced with the rationale that it decreases intra-renal

pressure, makes stone extraction more efficient and provides better vision due to lesser “dust-storm†formation

Superperc was a terminology that was initially used with a 10-14 Fr suction sheath but the subsequent  generation sheaths are available up to 21 Fr and the use of the term is not restricted to sheath size

For large size of stone there have been studies that have proved the superiority of using suction sheath by decreasing operating time and increasing the stone-free rate. There is evidence to support the use of suction sheath in the presence of pyonephrosis. However there is a gap in the knowledge when it comes to use of a suction sheath in medium sized stones

To add to the existing knowledge and bridge the gap of a randomised control trial comparing miniperc with and without a suction sheath for medium size stones, in this study, we compare Mini-PCNL with and without a suction sheath in renal calculi upto 3 cm in size.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Renal stones less than 3 cm and planned for mini PCNL.

排除标准

  • Patient not willing Patient not consenting Patient not fitting in inclusion criteria Renal anatomical abnormalities Active UTI Pregnancy.

结局指标

主要结局

Post procedure Infection (fever, sepsis)

时间窗: 72 hours

次要结局

  • Operating times(24 hours)
  • Post operative complications(72 hours)
  • stone free rate(30 days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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