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CTRI Number  CTRI/2020/08/027415 [Registered on: 27/08/2020] Trial Registered Prospectively
Last Modified On: 21/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Monopolar Versus Bipolar Transurethral Resection of the Prostate in patients with Benign Prostatic Enlargement 
Scientific Title of Study   Monopolar Versus Bipolar Transurethral Resection of the Prostate in patients with Benign Prostatic Enlargement: A Prospective Randomized Comparative Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Ranjan 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Urology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7835817324  
Fax    
Email  dr.rohitranjan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kim Jaccob Mammen 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Urology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9814034185  
Fax    
Email  kjmammen@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohit Ranjan 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Urology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7835817324  
Fax    
Email  dr.rohitranjan@gmail.com  
 
Source of Monetary or Material Support  
Department of urology, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand- 249203 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  Department of Urology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand. 
Type of Sponsor  Government medical college 
 
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 Rohit Ranjan  All India Institute of Medical Sciences, Rishikesh  Department of urology, All India Institute of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL 
7835817324

dr.rohitranjan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bipolar TURP (B-TURP)   Its newly introduced modification, bipolar TURP (B-TURP), promises to overcome its most prominent shortcomings, namely bleeding and dilutional hyponatremia. Literature is conflicting regarding merits of B-TURP over M-TURP, so we have decided to conduct this study. 
Comparator Agent  Monopolar TURP (M-TURP)  Monopolar transurethral resection of prostate (M-TURP) is considered the gold standard for the management of bladder outlet obstruction due to BPH. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  1. Age – >50 years.
2.All patients of lower urinary tract symptoms (LUTS) not responding to medical treatment.
3. Prostate size: 30 to 100 grams.
4. IPSS score >7.
 
 
ExclusionCriteria 
Details  1. Patients with history of prior TURP, Carcinoma Prostate.
2. BPH with associated conditions (Bladder calculus, bladder diverticula, bladder tumour, urethral stricture).
3. Patients with comorbidities who are unfit for surgery.
4. Neurogenic bladder.
5. Patients who did not give written informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Objective (Post voiding residual urine-PVR, and Maximum urine flow rate- Qmax) parameters.
2. Subjective (IPSS score and quality of life-QoL) parameters.
 
1 week, 1 month, 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. Perioperative parameters (Change in Haemoglobin, Sodium, Potassium; resection time, obturator jerk, TUR syndrome, catheter duration, amount of irrigation fluid used and its duration, hospital stay, failed TWOC- trial of voiding without catheter).
2. Complications, if any (According to the modified clavien grading system).
3. Re-operation rate.
 
Pre-operative phase, Immediate post-operate phase and after 24 hours (for blood parameters).

1 week, 1 month and 3 months (for other parameters) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   28/08/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Benign prostatic hyperplasia (BPH) is a common disease in middle aged and elderly men; and one of the most common etiology of lower urinary tract symptoms (LUTS). It may cause urinary urgency, frequency, nocturia, dysuria, and complications such as urinary tract infection, bladder stones, and hydronephrosis that sharply affect the quality of life (QOL). Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased. Therefore, prompt and effective interventions are necessary for treating BPH. It can be treated with pharmacotherapies and with surgery. Usually, surgery is needed to achieve satisfactory outcomes when patient is refractory to medical management.

Monopolar transurethral resection of prostate (M-TURP) is considered the gold standard for the management of bladder outlet obstruction due to BPH. Its newly introduced modification, bipolar TURP (B-TURP), promises to overcome its most prominent shortcomings, namely bleeding and dilutional hyponatremia. Literature is conflicting regarding merits of B-TURP over M-TURP, so we have decided to conduct this study.

 
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