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临床试验/CTRI/2024/12/078061
CTRI/2024/12/078061已完成4 期

A Comparative study of early versus late removal of per urethral catheter after anterior anastomotic and buccal mucosal onlay urethroplasty.

Sai Bharath Nandula1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Extravasation rates, duration of catheterization.

研究概览

简要总结

This is a parallel arm, randomized controlled study in which after urethroplasty surgery patients are followed up. Early removal of catheter has advantages of reduced urinary tract infection rates, better comfort to the patient and reduced recurrence rate of stricture, In the intervention group, per urethral urethrogram  is done  7 days early than comparator group which is within the optimum range of duration of catheterization. The extravasation rates are measured and catheter is removed when there is no extravasation. The extravasation rates, duration of catheterization and recurrence rates of both groups are compared and the feasibility of early removal is to be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
Male

入选标准

  • Patients diagnosed with urethral stricture disease and who underwent anastomotic and buccal mucosal onlay urethroplasty.

排除标准

  • Patients with history of previous repair, chronic kidney disease, uncontrolled diabetes mellitus and who received radiotherapy.

结局指标

主要结局

Extravasation rates, duration of catheterization.

时间窗: Extravasation rates on 7th, 14th for anastomotic urethroplasty and 14th and 21st day for buccal mucosal onlay urethroplasty. Duration of catheterization measured on 21st day.

次要结局

  • Recurrence of stricture rates.(Recurrence rates studied at 3 & 6 months after surgery.)

研究者

发起方
Sai Bharath Nandula
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sai Bharath Nandula

IPGMER and SSKM Hospital, Kolkata

研究点 (1)

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