The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.
NCT ID: NCT06168708
Last Updated: 2023-12-13
Study Results
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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RECRUITING
NA
220 participants
INTERVENTIONAL
2023-12-07
2024-07-07
Brief Summary
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the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Garamicin group
the participants in this arm will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
Transurethral resection of the prostate (TURP)
TURP with addition of gentamicin on irrigation fluid to reduce infectious complications
Gentamicin
gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
control group
the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).
Transurethral resection of the prostate (TURP)
TURP with addition of gentamicin on irrigation fluid to reduce infectious complications
normal saline
normal saline (2 ml) on the irrigation solution (placebo)
Interventions
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Transurethral resection of the prostate (TURP)
TURP with addition of gentamicin on irrigation fluid to reduce infectious complications
Gentamicin
gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
normal saline
normal saline (2 ml) on the irrigation solution (placebo)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Renal impairment
* active UTI
* urethral strictures
45 Years
80 Years
MALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ahmed Zoeir
faculty of medicine, Tanta, ElGeish street, Egypt
Locations
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Urolgy Departement, Faculty of Medicine, Tanta University
Tanta, Outside U.S./Canada, Egypt
Countries
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Central Contacts
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Facility Contacts
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Ahmed G. Zoeir, Ph D
Role: primary
Other Identifiers
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35121/12/21
Identifier Type: -
Identifier Source: org_study_id