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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01849835
Collaborator
(none)
120
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: trans-rectal to perform the prostate biopsy
  • Procedure: trans-perineal to perform the prostate biopsy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the rate of positive detections [1year]

    Secondary Outcome Measures

    1. the incidence rate of each complication [1 year]

    Other Outcome Measures

    1. pain level assessed by visual analogue scale [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • prostate-specific antigen > 4ng/ml

    • Palpation is positive

    Exclusion Criteria:

    • older than 80y

    • prostate-specific antigen > 100 ng/ml

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 10Th Hospital of Tongji University Shanghai Shanghai China 200072

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Le-hang Guo, Principal Investigator, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT01849835
    Other Study ID Numbers:
    • tongji10us
    • tongji10-us1
    First Posted:
    May 9, 2013
    Last Update Posted:
    May 6, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Le-hang Guo, Principal Investigator, Shanghai 10th People's Hospital
    rate of positive detection
    Additional relevant MeSH terms:
    Menthol

    Study Results

    No Results Posted as of May 6, 2014