| CTRI Number |
CTRI/2024/08/072009 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| 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
|
A prospective randomised study comparing the outcome of bipolar enucleation of prostate with
transurethral resection of prostate(TURP) and Thulium laser enucleation of prostate(ThuLEP) |
|
Scientific Title of Study
|
Prospective randomised study comparing the outcome of Bipolar enucleation of prostate with transurethral resection of prostate (TURP)and Thulium laser enucleation of prostate(ThuLEP) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smita Verma |
| Designation |
Resident |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of urology , IPGMER, Kolkata, West Bengal
PIN code - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
7985038794 |
| Fax |
|
| Email |
Smita.verma92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debansu Sarkar |
| Designation |
Professor |
| Affiliation |
IPGMER |
| Address |
Department of Urology , IPGMER, Kolkata , West Bengal
PIN code 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830010826 |
| Fax |
|
| Email |
dedebanshu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debansu Sarkar |
| Designation |
Professor |
| Affiliation |
IPGMER |
| Address |
Department of Urology , IPGMER, Kolkata , West Bengal
PIN code 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830010826 |
| Fax |
|
| Email |
dedebanshu@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER , Kolkata, West Bengal, INDIA
PIN code - 700020 |
|
|
Primary Sponsor
|
| Name |
Smita Verma |
| Address |
Department of urology , IPGMER, Kolkata , West Bengal
PIN code 700020 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Smita Verma |
IPGMER |
Department of UROLOGY, IPGMER, A.J.C.Bose road, Kolkata, West Bengal ,
PIN code 700020
Kolkata
WEST BENGAL |
7985038794
Smita.verma92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER research oversight committee |
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 enucleation of prostate |
Bipolar enucleation of prostate is a new surgical modality of treatment for prostatomegaly with bothersome symptoms. In this modality enlarged prostatic lobes are enucleated starting from 5 and 7 o’ clock position and towards bladder neck. When enucleation is reached till bladder neck then enucleated lobes are resected with no bleeding . Another option is that enucleated lobes are pushed into bladder and divided into pieces with morcellator. At the end , morcellated prostatic tissue is removed from bladder with Ellik evaluator. In this procedure, Normal saline ( 0.9%) is used as irritant fluid. |
| Comparator Agent |
Transurethral resection of prostate ( TURP) and thulium laser enucleation of prostate ( ThuLEP) |
Surgical treatment for enlarged prostate with bothersome symptoms. Gold standard is Transurethral resection of prostate ( TURP) and another newer modality is thulium laser
enucleation of prostate ( ThuLEP).
In TURP, enlarged prostatic lobes are removed in the form of chips with resectoscope and irritant fluid being 1.5% glycine.
In ThuLEP , enlarged prostatic lobes are enucleation with the help of thulium laser . Enucleated lobes are pushed into bladder and divided into fragments with the help of morcellator. These divided prostatic tissue are removed from bladder with ellik evacuator. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
Bothersome LUTS with failed medical management
Maximum flow rate less than 15 millilitre per second
Complications secondary to BPH- recurrent hematuria of prostatic pathology
Refractory urinary retention
Recurrent urinary tract infection
|
|
| ExclusionCriteria |
| Details |
Neurogenic bladder
High bladder neck
Diagnosed prostatic cancer |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and efficacy of bipolar enucleation of prostate |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare intraoperative , immediate postoperative and short term outcome of TURP, ThuLEP and bipolar enucleation of prostate |
One year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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="1"
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
|
A randomized study to compare the outcome ( intraoperative, immediate post operative and short term ) of bipolar enucleation of prostate with transurethral resection of prostate (TURP) and thulium laser enucleation of prostate ( ThuLEP). Patients with prostatomegaly ( bothersome LUTS and complications of prostatomegaly) attending outdoor will be recruited for study ( after applying exclusion criteria). Patients will undergo any of the three surgical procedures and intraoperative ( operative time , weight of respected tissue) ,immediate post op ( drop in hemoglobin, traction duration , need for blood transfusion , change in sodium level, need for irrigation , clot retention , re catheterisation , TUR syndrome , hospital stay ) and short term( Qmax , Qavg, PVR , SUI, development of urethral structure , re- do surgery ) outcome will be compared. |