Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001235796
Ethics application status
Approved
Date submitted
6/11/2013
Date registered
12/11/2013
Date last updated
12/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prophylactic antibiotics irrigation in seminal vesicoscopy
Scientific title
Outcome comparison of seminal vesicoscopy for patients with hemospermia with or without prophylactic antibiotics irrigation
Secondary ID [1] 283524 0
Nil
Universal Trial Number (UTN)
U1111-1149-9621
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemospermia 290444 0
Condition category
Condition code
Renal and Urogenital 290833 290833 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
topical irrigation of prophylactic antibiotics at the end of seminal vesicoscopy; amikacin 1.0g/20ml and 10ml for each seminal vesicle was irrigated only once for 1 minute at the close end of surgery. All the patients have one-month follow-up.
Intervention code [1] 288227 0
Prevention
Comparator / control treatment
In treatment group topical irrigation of antibiotics was used while in control group no topical irrigation of antibiotics.
Control group
Active

Outcomes
Primary outcome [1] 290834 0
evaluation of hemospermia by semen test
Timepoint [1] 290834 0
one month after surgery
Secondary outcome [1] 305386 0
infection of seminal vesicle by transrectal ultrasound examination
Timepoint [1] 305386 0
one month after surgery

Eligibility
Key inclusion criteria
patients with hemospermia
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
prostate cancer; bladder cancer

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was “off-site”
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
usually in clinic at least 30 patients in each group is necessary for strict statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/11/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5572 0
China
State/province [1] 5572 0
shanghai

Funding & Sponsors
Funding source category [1] 288222 0
Hospital
Name [1] 288222 0
shanghai changhai hospital 1255 funding
Country [1] 288222 0
China
Primary sponsor type
Individual
Name
zhou tie
Address
changhai hospital committee
changhai road 168#, shanghai 200433
Country
China
Secondary sponsor category [1] 286945 0
Individual
Name [1] 286945 0
sun yinghao
Address [1] 286945 0
changhai hospital committee
changhai road 168#, shanghai 200433
Country [1] 286945 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44114 0
Prof zhou tie
Address 44114 0
shanghai changhai hospistal; changhai road 168#, shanghai ;200433
Country 44114 0
China
Phone 44114 0
+86 2113918360523
Fax 44114 0
Email 44114 0
[email protected]
Contact person for public queries
Name 44115 0
zhou tie
Address 44115 0
shanghai changhai hospistal; changhai road 168#, shanghai ,200433
Country 44115 0
China
Phone 44115 0
+86 2113918360523
Fax 44115 0
Email 44115 0
[email protected]
Contact person for scientific queries
Name 44116 0
zhou tie
Address 44116 0
shanghai changhai hospistal; changhai road 168#, shanghai ;200433
Country 44116 0
China
Phone 44116 0
+86 2113918360523
Fax 44116 0
Email 44116 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.