Back to results

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

Primary Purpose

Adenocarcinoma of Prostate

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

intrarectal lidocaine gel

periprostatic nerve blockade

About this trial

This is an interventional diagnostic trial for Adenocarcinoma of Prostate focused on measuring prostate biopsy, local anesthesia, cancer detection rate.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Bagcilar Training and Research Hospital-Depertmant of urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

intrarectal lidocaine gel

periprostatic nerve blockade

Arm Description

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

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.

Outcomes

Primary Outcome Measures

cancer detection rate with anesthesia type

Secondary Outcome Measures

Full Information

NCT ID

NCT02025361

First Posted

December 17, 2013

Last Updated

January 16, 2018

Sponsor

Bagcilar Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02025361

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bagcilar Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of Prostate

Keywords

prostate biopsy, local anesthesia, cancer detection rate.

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

422 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intrarectal lidocaine gel

Arm Type

Experimental

Arm Description

Arm Title

periprostatic nerve blockade

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

intrarectal lidocaine gel

Other Intervention Name(s)

No name

Intervention Description

intrarectal local anesthetic application

Intervention Type

Drug

Intervention Name(s)

periprostatic nerve blockade

Other Intervention Name(s)

No name

Intervention Description

periprostatic local anesthetic application

Primary Outcome Measure Information:

Title

cancer detection rate with anesthesia type

Time Frame

finally pathologic evaluation within 2-3 weeks

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mustafa z temiz

Organizational Affiliation

bagcilar training and research hospital-depertmant of urology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bagcilar Training and Research Hospital-Depertmant of urology

City

Istanbul

State/Province

Bagcilar

ZIP/Postal Code

34100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs