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

Adenocarcinoma of Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025361
• Other study ID #: Cancer detection in TRUS-Bx
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2013
• Last updated: January 16, 2018
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2018
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Prostate
• Prostatic Neoplasms

Intervention

Drug:
• intrarectal lidocaine gel
intrarectal local anesthetic application
• periprostatic nerve blockade
periprostatic local anesthetic application

Locations

Country	Name	City	State
Turkey	Bagcilar Training and Research Hospital-Depertmant of urology	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cancer detection rate with anesthesia type		finally pathologic evaluation within 2-3 weeks