| 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
|
|
|
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
|
|
|
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 standardâ€. 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. |