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

Sponsor
Bagcilar Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02025361
Collaborator
(none)
422
Enrollment
1
Location
2
Arms
46
Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: intrarectal lidocaine gel
  • Drug: periprostatic nerve blockade
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
422 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: intrarectal lidocaine gel
intrarectal local anesthetic application
Other Names:
  • No name

    		•
    Experimental: 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.

    Drug: periprostatic nerve blockade
    periprostatic local anesthetic application
    Other Names:
  • No name

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cancer detection rate with anesthesia type [finally pathologic evaluation within 2-3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bagcilar Training and Research Hospital-Depertmant of urology Istanbul Bagcilar Turkey 34100

    Sponsors and Collaborators

    • Bagcilar Training and Research Hospital

    Investigators

    • Principal Investigator: mustafa z temiz, bagcilar training and research hospital-depertmant of urology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mustafa Zafer Temiz, principal investigator, Bagcilar Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02025361
    Other Study ID Numbers:
    • Cancer detection in TRUS-Bx
    First Posted:
    Jan 1, 2014
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mustafa Zafer Temiz, principal investigator, Bagcilar Training and Research Hospital
    prostate biopsy, local anesthesia, cancer detection rate.
    Additional relevant MeSH terms:
    Adenocarcinoma
    Lidocaine

    Study Results

    No Results Posted as of Jan 18, 2018