Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Incidence of infectious complications within 30 days post-biopsyTimepoint: Incidence of infectious complications within 30 days post-biopsy | — |
Secondary
| Measure | Time 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
AIIMS Bhopal