| 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
|
|
|
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
|
|
|
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. |