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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Le-hang Guo, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01849835
First Posted: May 9, 2013
Last Update Posted: May 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Le-hang Guo, Shanghai 10th People's Hospital
  Purpose
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 Intervention
Complication Procedure: trans-rectal to perform the prostate biopsy Procedure: trans-perineal to perform the prostate biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Le-hang Guo, Shanghai 10th People's Hospital:

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

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

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

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: April 29, 2013
First Posted: May 9, 2013
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