The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.
NCT06168708 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2023-12-13
Summary
The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.
the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).
Conditions
- Post-TURP Infectious Complications
Interventions
- PROCEDURE
-
Transurethral resection of the prostate (TURP)
TURP with addition of gentamicin on irrigation fluid to reduce infectious complications
- DRUG
-
Gentamicin
gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
- DRUG
-
normal saline
normal saline (2 ml) on the irrigation solution (placebo)
Sponsors & Collaborators
-
Tanta University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-07
- Primary Completion
- 2024-06-07
- Completion
- 2024-07-07
Countries
- Egypt
Study Locations
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