The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.

Tanta University

Status: Enrolling

Conditions: Post-TURP Infectious Complications

Treatments: Procedure: Transurethral resection of the prostate (TURP); Drug: Gentamicin; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06168708

35121/12/21

Details and patient eligibility

About

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).

Full description

220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who 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) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, & Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.

Enrollment: 220 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients with enlarged prostate presenting with LUTS or urine retention

Exclusion criteria

• Unfit patients
• Renal impairment
• active UTI
• urethral strictures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Garamicin group

Active Comparator group

Description:

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)

Treatment:

Drug: Gentamicin

Procedure: Transurethral resection of the prostate (TURP)

control group

Placebo Comparator group

Description:

the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).

Treatment:

Procedure: Transurethral resection of the prostate (TURP)

Drug: normal saline