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

NCT ID: NCT02025361

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Adenocarcinoma of Prostate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

intrarectal lidocaine gel

Intervention Type DRUG

intrarectal local anesthetic application

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.

Group Type EXPERIMENTAL

periprostatic nerve blockade

Intervention Type DRUG

periprostatic local anesthetic application

Interventions

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intrarectal lidocaine gel

intrarectal local anesthetic application

Intervention Type DRUG

periprostatic nerve blockade

periprostatic local anesthetic application

Intervention Type DRUG

Other Intervention Names

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No name No name

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mustafa Zafer Temiz

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mustafa z temiz

Role: PRINCIPAL_INVESTIGATOR

bagcilar training and research hospital-depertmant of urology

Locations

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Bagcilar Training and Research Hospital-Depertmant of urology

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Cancer detection in TRUS-Bx

Identifier Type: -

Identifier Source: org_study_id

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