| CTRI Number |
CTRI/2024/09/074019 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized trial to compare the safety of two modes (trasnrectal and transperineal) of prostate biopsy |
|
Scientific Title of Study
|
A comparison of Safety of Transrectal Prostate Biopsy to Transperineal Prostate Biopsy A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj yadav |
| Designation |
senior resident |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of urology AIIMS Campus Rd AIIMS Campus Saket Nagar Habib Ganj Bhopal Madhya Pradesh 462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
7376299254 |
| Fax |
|
| Email |
manojyad15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kumar Madhavan |
| Designation |
Associate professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of urology AIIMS Campus Rd AIIMS Campus Saket Nagar Habib Ganj Bhopal Madhya Pradesh 462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9555616040 |
| Fax |
|
| Email |
kumarm.urology@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr kumar Madhavan |
| Designation |
Associate professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of urology AIIMS Campus Rd AIIMS Campus Saket Nagar Habib Ganj Bhopal Madhya Pradesh 462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9555616040 |
| Fax |
|
| Email |
kumarm.urology@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| DEPT OF UROLOGY, AIIMS BHOPAL, SAKET NAGAR, BHOPAL- 462026, INDIA |
|
|
Primary Sponsor
|
| Name |
AIIMS BHOPAL |
| Address |
Department of urology AIIMS Campus Rd AIIMS Campus Saket Nagar Habib Ganj Bhopal Madhya Pradesh 462026 |
| Type of Sponsor |
Other [AIIMS BHOPAL] |
|
|
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 Manoj Yadav |
AIIMS Bhopal |
Department of urology AIIMS Campus Rd AIIMS Campus Saket Nagar Habib Ganj Bhopal Madhya Pradesh 462026
Bhopal
MADHYA PRADESH |
7376299254
manojyad15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The AlIMS, Bhopal IHEC-SR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transperineal prostate biopsy |
Ultra sound guided Transperineal prostate biopsy. This is a procedure to take biopsy of the prostate. The procedure is accepted worldwide and is mentioned in standard guidelines. The procedure is done on daycare basis and takes around 20 minutes. |
| Intervention |
Transrectal prostate biopsy |
Trans rectal ultra sound guided prostate biopsy. This is a procedure to take biopsy of the prostate. The procedure is accepted worldwide and is mentioned in standard guidelines. The procedure is done on daycare basis and takes around 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients aged 40 years and above.
2. Patients with a clinical indication for prostate biopsy (elevated PSA levels, abnormal digital rectal exam, or suspicious MRI findings).
3. Patients who provide written informed consent.
4. Patients who are capable of understanding and complying with study requirements and procedures.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of allergic reaction to iodine or antibiotics used in the study.
2. Patients with a history of rectal surgery.
3. Patients with active urinary tract infection or prostatitis at the time of biopsy.
4. Patients with immunocompromised status (e.g., HIV, ongoing chemotherapy).
5. Patients currently receiving anticoagulant therapy that cannot be safely interrupted for the biopsy procedure.
6. Patients unwilling or unable to comply with follow-up requirements
|
|
|
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 |
| Incidence of infectious complications within 30 days post-biopsy |
Incidence of infectious complications within 30 days post-biopsy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Pain scores: Assessed using Visual Analog Scale (0-10) immediately post-procedure
b) Patient-Reported Outcome Measures (PROMs):
c) Patient satisfaction: Custom questionnaire at 30 days post-procedure
d) cancer detection rate
e) rate of need to second biopsy
d) Other complications: |
At base line, immediate post op
at 15 and 30 day |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
28/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Purpose: To compare the safety of transrectal prostate biopsy versus
transperineal prostate biopsy by evaluating the incidence of infectious
complications, specifically sepsis, fever, and urinary tract infections (UTIs).Hypothesis:There is no difference in the incidence of infectious complications or
patient-reported outcomes between transrectal prostate biopsy and transperineal
prostate biopsy.
|