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

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ClinicalTrials.gov Identifier: NCT01849835
Recruitment Status : Unknown
Verified May 2014 by Le-hang Guo, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2013
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Le-hang Guo, Shanghai 10th People's Hospital

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
Complication Procedure: trans-rectal to perform the prostate biopsy Procedure: trans-perineal to perform the prostate biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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 Name: the puncture points are at the perineal



Primary Outcome Measures :
  1. the rate of positive detections [ Time Frame: 1year ]

Secondary Outcome Measures :
  1. the incidence rate of each complication [ Time Frame: 1 year ]

Other Outcome Measures:
  1. pain level assessed by visual analogue scale [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849835


Contacts
Contact: guo lehang, phd +8613764538305 gopp1314@hotmail.com

Locations
China, Shanghai
10Th Hospital of Tongji University Recruiting
Shanghai, Shanghai, China, 200072
Contact: guo lehang, phd    +8613764538305    gopp1314@hotmail.com   
Principal Investigator: xu huixiong, phd         
Sponsors and Collaborators
Shanghai 10th People's Hospital

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

Responsible Party: Le-hang Guo, Principal Investigator, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01849835     History of Changes
Other Study ID Numbers: tongji10us
tongji10-us1
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Le-hang Guo, Shanghai 10th People's Hospital:
rate of positive detection

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents