Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy

NCT02025361 | Completed Phase 4

• 1 other identifier: Cancer detection in TRUS-Bx
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief Summary

Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient tolerance may improve the protocol effectiveness and quality. Adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in TRUS-Bx.

Conditions

Adenocarcinoma of Prostate

Keywords

prostate biopsy, local anesthesia, cancer detection rate.

Outcome Measures

Primary Outcomes (1)

• cancer detection rate with anesthesia type

  finally pathologic evaluation within 2-3 weeks

Study Arms (2)

intrarectal lidocaine gel

EXPERIMENTAL

transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure % 2 lidocaine hydrochloride gel instilated into the rectum for local anesthesia

Drug: intrarectal lidocaine gel

periprostatic nerve blockade

EXPERIMENTAL

transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure transrectal ultrasound guided 10 ml prilocaine and serum physiologic blend (5ml %2 prilocaine and 5 ml serum physiologic) injected separetly 5ml right and 5ml left junction between the prostate base and seminal vesicle.

Drug: periprostatic nerve blockade

Interventions

intrarectal lidocaine gel DRUG

intrarectal local anesthetic application

Also known as: No name

intrarectal lidocaine gel

periprostatic nerve blockade DRUG

periprostatic local anesthetic application

Also known as: No name

periprostatic nerve blockade

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent transrectal ultrasound guided prostate biopsy because of elevated serum PSA levels and/or suspicious rectal examination of prostate.

You may not qualify if:

• Previous TRUS-Bx and prostatic operations(TUR-P, open prostatectomy, etc..) history, treatment for prostate carcinoma, usage of finasteride and dutasteride.

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training and Research Hospital-Depertmant of urology

Istanbul, Bagcilar, 34100, Turkey (Türkiye)

Location

Study Officials

• mustafa z temiz

  bagcilar training and research hospital-depertmant of urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 1, 2014
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)