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A randomized trial to compare the safety of two modes (trasnrectal and transperineal) of prostate biopsy

A comparison of Safety of Transrectal Prostate Biopsy to Transperineal Prostate Biopsy A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074019
Enrollment
500
Registered
2024-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: 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

Sponsors

AIIMS BHOPAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Incidence of infectious complications within 30 days post-biopsyTimepoint: Incidence of infectious complications within 30 days post-biopsy

Secondary

MeasureTime frame
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:Timepoint: At base line, immediate post op at 15 and 30 day

Countries

India

Contacts

Public ContactDr kumar Madhavan

AIIMS Bhopal

kumarm.urology@aiimsbhopal.edu.in9555616040

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026