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NCT01849835 Clinical Trial

A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate

Complication Clinical Trial

— RCT  

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01849835
Other study ID # tongji10us
Secondary ID tongji10-us1
Status Recruiting
Phase N/A
First received April 29, 2013
Last updated May 4, 2014
Start date January 2013

Study information
Verified date May 2014
Source Shanghai 10th People's Hospital
Contact guo lehang, phd
Phone +8613764538305
Email gopp1314@hotmail.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Male
Age group N/A to 80 Years
Eligibility Inclusion Criteria:

- prostate-specific antigen > 4ng/ml

- Palpation is positive

Exclusion Criteria:

- older than 80y

- prostate-specific antigen > 100 ng/ml

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• trans-rectal to perform the prostate biopsy
the puncture points are at the rectal
• trans-perineal to perform the prostate biopsy
the puncture points are at the perineal

Locations
Country Name City State
China 10Th Hospital of Tongji University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Evidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate

Outcome
Type Measure Description Time frame Safety issue
Other pain level assessed by visual analogue scale 1 year Yes
Primary the rate of positive detections 1year Yes
Secondary the incidence rate of each complication 1 year Yes
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