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临床试验/CTRI/2022/01/039199
CTRI/2022/01/039199尚未招募不适用

A randomized control trial to evaluate the safety and feasibility of mono polar transurethral resection of prostate without post-operative urethral catheter traction in benign prostatic hyperplasia patients in a teritary care institute

Abhineeth K P1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
2) to compare the post operative blood loss

研究概览

简要总结

Thisstudy is a randomized, double blind, parallel group, clinical trial to evaluatethe safety and feasibility of Monopolar Transurethral resection of prostatewithout postoperative urinary catheter traction. The gold standardsurgical management of Benign prostatic hyperplasia is transurethral resectionof prostate. An electrified wire loop is used to remove the part ofthe prostate between the bladder neck and the verumontanum up to thedepth of the surgical capsule. Incomplete hemostasis during the operation makespost-surgical bleeding one of the major drawbacks of transurethral resection ofprostate.Traction with a urethral catheter can decrease   bleeding after transurethral resection ofprostate. There is no standard protocol for the post operative management ofpatients with intraoperatively achieved hemostasis. Patients can be eithergiven traction with a urethral catheter or can avoid traction. With carefulcoagulation of venous and arterial bleeding, hemostasis can be achieved, thusavoiding the need for traction after the surgery. Also, traction results inincreased pain and analgesic consumption in patients.  In this study, we will evaluate the need fortraction if hemostasis can be secured intraoperatively, which will help todecrease the morbidity associated with traction. This will be achieved bycomparing the pain score and post operative blood loss of patients with urethralcatheter traction and without urethral catheter traction.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • prostate size of 30-80 ml.

排除标准

  • Patients refusing to participate/give consent.
  • Patients failed to achieve Intraoperative hemostasis.
  • Patients with both BPH and bladder tumor 4) Patients with both BPH and bladder stone 5) Patients with both BPH and Urethral stricture disease 6) Patients with both BPH and meatal stenosis.

结局指标

主要结局

2) to compare the post operative blood loss

时间窗: 1) pain scores - using visual analogue score will be recorded at 6 hour,12 hour and 18 hour post surgery | 2) Blood loss will be calculated using Bourke’s formula , preopertaive hematocrit and postoperative hematocrit will be evaluated at post operative day one.

1) To compare pain scores

时间窗: 1) pain scores - using visual analogue score will be recorded at 6 hour,12 hour and 18 hour post surgery | 2) Blood loss will be calculated using Bourke’s formula , preopertaive hematocrit and postoperative hematocrit will be evaluated at post operative day one.

次要结局

  • 1.To compare the duration of hospital stay.(2.To compare the incidence of bladder washouts and clot retention.)

研究者

发起方
Abhineeth K P
申办方类型
Other [self]

研究点 (1)

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