The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications: A Prospective Randomized Double Blinded Placebo Controlled Pilot Trial.
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:
• adult patients with enlarged prostate presenting with LUTS or urine retention
Locations
Other Locations
Egypt
Urolgy Departement, Faculty of Medicine, Tanta University
RECRUITING
Tanta
Contact Information
Primary
Ahmed G. Zoeir, Ph D
drahmedzoeir27@gmail.com
+201008634198
Backup
Ahmed A. Eissa, Ph D
ahmed.taha.eissa@gmail.com
01110304666
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2024-07-07
Participants
Target number of participants: 220
Treatments
Active_comparator: 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)
Placebo_comparator: control group
the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).
Related Therapeutic Areas
Sponsors
Leads: Tanta University