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临床试验/CTRI/2024/04/066287
CTRI/2024/04/066287尚未招募3 期

TO COMPARE THE EFFECTIVENSS OF MONOPOLAR AND BIPOLAR TRANSURETHRAL RESECTION OF PROSTATE IN THE TREATMENT OF BENIGN PROSTATIC HYPERTROPHY IN A TERTIARY CARE HOSPITAL AT IMPHAL, MANIPUR

AAKASH ADHIKARI1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年5月3日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
RESCTION TIME REQUIRED

研究概览

简要总结

In male reproductive system, prostate is one of the major accessory sex gland. As the age increases, under the influence of dihydrotestosterone and testosterone, prostate continue to enlarge. Benign prostatic hyperplasia (BPH) or Benign enlargement of prostate is one of the most common problems of aging males all over the world which causes variety of lower urinary tract symptoms (LUTS). It can lead to simple disturbances in work to severe restriction of day today activities leading to poor quality of life.  BPH starts as early as 40 years of age. The prevalence is greater than 50% by the age of 60 years and by the age of 85years BPH prevalence is as high as 90%. BPH produce wide variety of symptoms which are known as lower urinary tract symptoms (LUTS) which are obstructive and irritative symptoms, also known as voiding and storage symptoms respectively.

Treatment can vary from simple watchful waiting to open prostatectomy. In between the spectrum are medical management with alpha blockers or 5 alpha reductase inhibitors and minimally invasive and endoscopic procedures like Transurethral resection of prostate (TURP), Transurethral needle ablation of prostate (TUNA), transurethral ultrasound–guided laser induced prostatectomy (TULIP), transurethral vaporization of the prostate (TUVP), transurethral incision of prostate (TUIP).

Monopolar TURP is a gold standard and an established procedure and all other procedures are compared with it. With improvement in technology, Bipolar TURP is now increasingly done procedure for benign enlargement because of the advantage of reduced complications. But still monopolar TURP is the most commonly done procedure and is considered as “gold standard”.

The objective of the study is to compare the effectiveness of  monopolar vs bipolar transurethral resection of prostate in the treatment of benign prostatic hypertrophy.

This study will be done in patients requiring surgical intervention for benign prostatic hypertrophy.

Study variables will be resection time required (resection time will be calculated from the period of initiation of resection to the completion of resection), weight of tissues resected using electronic scale. Change in hemoglobin, change in hematocrit and change in the serum electrolyte (it will be compared by using the preoperative values with the values obtained in the immediate post-operative period), improvement in maximum flow rate (Qmax), post void residual urine and IPSS score. (these parameters will be compared by subjecting the patient to uroflowmetry in the pre-operative period and again after one month of intervention to note the change in the maximum urine flow rate and post void residual urine. similarly improvement of IPSS will be compared by asking the patient to fill the IPSS questionnaire preoperatively and at one month postoperative follow up).

 The patients will be followed up in the urology department according to the proforma.

Statistical analysis will be done by using IBM SPSS Version 29 for windows. Mean or median score will be calculated based on the disrtribution of scores. T-test will be used as a test of significance for comparing the outcome variables.

P-value equal to or less than 0.05 will be taken as statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN ENLARGEMENT OF PROSTATE REQUIRING SURGICAL INTERVENTION.

排除标准

  • PATIENTS WITH CANCER PROSTATE, URETHRAL STRICTURE, NEUROGENIC BLADDER, PROSTATITIS, ACTIVE URINARY TRACT INFECTION, PREVIOUS PROSTATE SURGERY, VESICAL CALCULUS, BLADDER DIVERTICULUM, UPPER URINARY TRACT CHANGES, ANKYLOSING SPONDYLITIS, COAGULOPATHY WILL BE EXCLUDED.

结局指标

主要结局

RESCTION TIME REQUIRED

时间窗: AT BASELINE

次要结局

  • 1. WEIGHT OF TISSUE RESECTED(2. DROP IN HEMOGLOBIN)

研究者

发起方
AAKASH ADHIKARI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

AAKASH ADHIKARI

REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL

研究点 (1)

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