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

NCT06168708 | Unknown

• 1 other identifier: 35121/12/21
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-TURP Infectious Complications

Outcome Measures

Primary Outcomes (1)

• infectious complications

  Post-TURP pyuria and bacteruria

  1 week and 1 month after removal of urethral catheter

Study Arms (2)

Garamicin group

ACTIVE COMPARATOR

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)

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

control group

PLACEBO COMPARATOR

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

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

Interventions

Transurethral resection of the prostate (TURP) PROCEDURE

TURP with addition of gentamicin on irrigation fluid to reduce infectious complications

Garamicin group; control group

Gentamicin DRUG

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

normal saline DRUG

normal saline (2 ml) on the irrigation solution (placebo)

control group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Urolgy Departement, Faculty of Medicine, Tanta University

Tanta, Outside U.S./Canada, 6620010, Egypt

RECRUITING

MeSH Terms

Interventions

Transurethral Resection of Prostate; Gentamicins; Saline Solution

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Aminoglycosides; Glycosides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ahmed G. Zoeir, Ph D

CONTACT

+201008634198; drahmedzoeir27@gmail.com

Ahmed A. Eissa, Ph D

CONTACT

01110304666; ahmed.taha.eissa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faculty of medicine, Tanta, ElGeish street, Egypt

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 7, 2023
• Primary Completion: June 7, 2024
• Study Completion: July 7, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

EG (1)