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CTRI Number  CTRI/2024/04/066287 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO COMPARE MONOPOLAR AND BIPOLAR TRANSURETHRAL RESECTION OF PROSTATE FOR TREATMENTING PROSTATE ENLARGEMENT 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AAKASH ADHIKARI 
Designation  SENIOR RESIDENT MCh UROLOGY TRAINEE 
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL 
Address  HOUSE NO. 6 DR GAYATRI HOUSE LALABUNG TAKHELLAMBAM LEIKAI THAMGMEIBAND IMPHAL WEST

Imphal West
MANIPUR
795004
India 
Phone  7896368291  
Fax    
Email  aakashadhikari683@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR AKOIJAM KAKU SINGH 
Designation  PROFESSOR AND HEAD DEPARTMENT OF UROLOGY 
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL  
Address  DEPARTMENT OF UROLOGY REGIONAL INSTITUTE OF MEDICAL SCIENCES LAMPHELPAT IMPHAL WEST IMPHAL

Imphal West
MANIPUR
795004
India 
Phone  8974057025  
Fax    
Email  drkakurims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KHUMUKCHAM SOMARENDRA 
Designation  ASSISTANT PROFESSOR DEPARTMENT OF UROLOGY  
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL  
Address  DEPARTMENT OF UROLOGY REGIONAL INSTITUTE OF MEDICAL SCIENCES LAMPHELPAT IMPHAL WEST IMPHAL

Imphal West
MANIPUR
795006
India 
Phone  9612165705  
Fax    
Email  drsomensingh@gmail.com  
 
Source of Monetary or Material Support  
REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL LAMPHELPAT IMPHAL WEST PIN 795004 
 
Primary Sponsor  
Name  AAKASH ADHIKARI 
Address  DEPARTMENT OF UROLOGY REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL IMPHAL WEST MANIPUR PIN 795004 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AAKASH ADHIKARI  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL  DEPARTMENT OF UROLOGY REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL LAMPHELPAT PO IMPHAL WEST IMPHAL PIN 795004
Imphal West
MANIPUR 
7896368291

aakashadhikari683@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N99-N99||Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIPOLAR TRANSURETHRAL RESCTION OF PROSTATE   TRANSURETHRAL RESCTION OF PROSTATE CAN BE DONE USING BIPOLAR AND MONOPOLAR CURRECT. WITH IMPROVED TECHNOLOGY AND REDUCED COMPLICATION, BIPOLAR TURP IS INCREASINGLY USED 
Comparator Agent  MONOPLAR TRANSURETHRAL RESCTION OF PROSTATE  MONOPOLAR TRANSURETHRAL RESCTION OF PROSTATE IS A GOLD STANDARD AND AN ESTABLISED PROCEDURE AND ALL OTHER TREATMENT MODALITIES ARE COMAPRED WITH IT 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN ENLARGEMENT OF PROSTATE REQUIRING SURGICAL INTERVENTION 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
RESCTION TIME REQUIRED  AT BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
1. WEIGHT OF TISSUE RESECTED
2. DROP IN HEMOGLOBIN
3. CHANGE IN HEMATOCRIT
4. CHANGE IN SERUM ELECTROLYTE
5. IMPROVEMENT OF MAXIMUM URINE FLOW RATE (Qmax) ON UROFLOWMETRY
6. POSTVOID RESIDUAL URINE
7. IMPROVEMENT OF IPSS ( International Prostate Symptom Score)  
CHANGE IN THE OUTCOMES WILL BE COMPARED WITH THE PREOPERATIVE VALUES  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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