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

NCT ID: NCT01849835

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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trans-rectal

trans-rectal to perform the prostate biopsy

Group Type EXPERIMENTAL

trans-rectal to perform the prostate biopsy

Intervention Type PROCEDURE

the puncture points are at the rectal

trans-perineal

trans-perineal to perform the prostate biopsy

Group Type EXPERIMENTAL

trans-perineal to perform the prostate biopsy

Intervention Type PROCEDURE

the puncture points are at the perineal

Interventions

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trans-rectal to perform the prostate biopsy

the puncture points are at the rectal

Intervention Type PROCEDURE

trans-perineal to perform the prostate biopsy

the puncture points are at the perineal

Intervention Type PROCEDURE

Other Intervention Names

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the puncture points are at the perineal

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* older than 80y
* prostate-specific antigen \> 100 ng/ml
Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Le-hang Guo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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10Th Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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guo lehang, phd

Role: CONTACT

+8613764538305

Facility Contacts

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guo lehang, phd

Role: primary

+8613764538305

References

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

Reference Type BACKGROUND

Other Identifiers

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tongji10-us1

Identifier Type: -

Identifier Source: secondary_id

tongji10us

Identifier Type: -

Identifier Source: org_study_id

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