Clinical trial
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.
Name
35121/12/21
Description
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).
Trial arms
Trial start
2023-12-07
Estimated PCD
2024-06-07
Trial end
2024-07-07
Status
Recruiting
Treatment
Transurethral resection of the prostate (TURP)
TURP with addition of gentamicin on irrigation fluid to reduce infectious complications
Arms:
Garamicin group, control group
Gentamicin
gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
Arms:
Garamicin group
normal saline
normal saline (2 ml) on the irrigation solution (placebo)
Arms:
control group
Size
220
Primary endpoint
infectious complications
1 week and 1 month after removal of urethral catheter
Eligibility criteria
Inclusion Criteria:
* adult patients with enlarged prostate presenting with LUTS or urine retention
Exclusion Criteria:
* Unfit patients
* Renal impairment
* active UTI
* urethral strictures
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}
Updated at
2023-12-13
1 organization
2 products
1 indication
Organization
Tanta UniversityProduct
GentamicinProduct
Normal Saline