| CTRI Number |
CTRI/2024/03/063862 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| 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
|
Comparing efficacy and safety of HoLEP against gold standard TURP in Indian population. |
|
Scientific Title of Study
|
A Randomized control trial comparing HoLEP versus TURP in the treatment of Benign Prostatic Hyperplasia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KUSHAL KUMAR |
| Designation |
Post Graduate Student |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department of General Surgery
I.G.M.C Shimla (H. P.)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9736210928 |
| Fax |
|
| Email |
DR.KKDOGRA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. PAWAN M KAUNDAL |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department of Urology
I.G.M.C Shimla (H. P.)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418085006 |
| Fax |
|
| Email |
drpawank19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KUSHAL KUMAR |
| Designation |
Post Graduate Student |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department of General Surgery
I.G.M.C Shimla (H. P.)
HIMACHAL PRADESH
171001
India |
| Phone |
9736210928 |
| Fax |
|
| Email |
DR.KKDOGRA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla |
|
|
Primary Sponsor
|
| Name |
Kushal Kumar |
| Address |
Indira Gandhi Medical College, Shimla |
| 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 |
| Kushal Kumar |
Indira Gandhi Medical College, Shimla |
ROOM NO. 507
UROLOGY DEPARTMENT INDIRA GANDHI MEDICAL COLLEGE-SHIMLA 171001
Shimla
HIMACHAL PRADESH |
9736210928
DR.KKDOGRA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE IGMC -SHIMLA |
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 |
Holmium laser enucleation of the prostate -HoLEP |
HoLEP is an alternate technique for enucleation of the prostate.
Frequency would be as per randomization.
Duration of last intervention would be on recruitment of last case i.e. 31 August 2024 |
| Comparator Agent |
Transurethral resection of the prostate (TURP) |
Transurethral resection of the prostate (TURP) which is considered as gold standard as surgical management of BPH will compared with HoLEP.
Frequency would be as per randomization.
Duration of last intervention would be on recruitment of last case i.e. 31 August 2024 |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion criteria:
1. BPH patient with prostatic volume greater than 30cc.
2. IPSS score of 8 or more.
3. urinary peak flow Qmax 15ml/sec or low
4. BPH with refractory urinary retention
5. BPH with recurrent UTI
6. BPH leading to obstructive uropathy and relieved following per urethral catheterization
7. Serum PSA greater than >4ng/ml with normal Biopsy
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Neurogenic bladder
2. Confirmed Carcinoma prostate
3. Those who doesn’t consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV) Peri-operative parameters include total operating time, resected tissue weight, drop in hemoglobin level, requirement of Blood transfusion, hospital stay, time for catheter removal. |
0,1 & 3 moth after suegery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV) |
0,1 & 3 moth after suegery |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
14/03/2024 |
| 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
|
In this RCT we would like compare the new surgical modality for prostate surgery HoLEP against TURP ( gold standard) in terms of perioperative and postoperative parameters in Indian population.
|