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

Not Applicable

Recruiting

• Conditions: Post-TURP Infectious Complications
• Interventions: Procedure: Transurethral resection of the prostate (TURP); Drug: normal saline; Drug: Gentamicin

• Registration Number: NCT06168708
• Lead Sponsor: Tanta University

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study Start: 2023-12-07
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-06-07
• Study Completion: 2024-07-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Transurethral resection of the prostate (TURP)	the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).
control group	normal saline	the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).
Garamicin group	Transurethral resection of the prostate (TURP)	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)
Garamicin group	Gentamicin	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)

Primary Outcome Measures

Name	Time	Method
infectious complications	1 week and 1 month after removal of urethral catheter	Post-TURP pyuria and bacteruria

Trial Locations

Locations (1)

Urolgy Departement, Faculty of Medicine, Tanta University; 🇪🇬 Tanta, Outside U.S./Canada, Egypt