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Clinical Trials/NCT02025361
NCT02025361
Completed
Phase 4

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

Bagcilar Training and Research Hospital1 site in 1 country422 target enrollmentFebruary 2009

Overview

Phase
Phase 4
Intervention
intrarectal lidocaine gel
Conditions
Adenocarcinoma of Prostate
Sponsor
Bagcilar Training and Research Hospital
Enrollment
422
Locations
1
Primary Endpoint
cancer detection rate with anesthesia type
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

In transrectal ultrasound guided prostate biopsy ultrasound's probe manipulation is necessary for effective biopsy. Patient discomfort and pain frequently occurs with manipulation of probe during transrectal ultrasound guided prostate biopsy and this situation may qualify of the achievement of this procedure. In this study, we aimed to describe the impact of different two local anesthesia types on cancer detection rate in transrectal ultrasound guided prostate biopsy.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
December 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Sponsor
Bagcilar Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mustafa Zafer Temiz

principal investigator

Bagcilar Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

intrarectal lidocaine gel

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

Intervention: intrarectal lidocaine gel

periprostatic nerve blockade

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.

Intervention: periprostatic nerve blockade

Outcomes

Primary Outcomes

cancer detection rate with anesthesia type

Time Frame: finally pathologic evaluation within 2-3 weeks

Study Sites (1)

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