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

May 4, 2014 updated by: Le-hang Guo, Shanghai 10th People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • 10Th Hospital of Tongji University
        • Contact:
        • Principal Investigator:
          • xu huixiong, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • prostate-specific antigen > 4ng/ml
  • Palpation is positive

Exclusion Criteria:

  • older than 80y
  • prostate-specific antigen > 100 ng/ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: trans-rectal
trans-rectal to perform the prostate biopsy
Procedure: trans-rectal to perform the prostate biopsy
the puncture points are at the rectal
Experimental: trans-perineal
trans-perineal to perform the prostate biopsy
Procedure: trans-perineal to perform the prostate biopsy
the puncture points are at the perineal
Other Names:
  • the puncture points are at the perineal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of positive detections
Time Frame: 1year
1year

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence rate of each complication
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
pain level assessed by visual analogue scale
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 4, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tongji10us
  • tongji10-us1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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