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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| control group | Placebo Comparator | the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transurethral resection of the prostate (TURP) | Procedure | TURP with addition of gentamicin on irrigation fluid to reduce infectious complications |
|
| Measure | Description | Time Frame |
|---|---|---|
| infectious complications | Post-TURP pyuria and bacteruria | 1 week and 1 month after removal of urethral catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed G. Zoeir, Ph D | Contact | +201008634198 | +2 | drahmedzoeir27@gmail.com |
| Ahmed A. Eissa, Ph D | Contact | 01110304666 | +2 | ahmed.taha.eissa@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urolgy Departement, Faculty of Medicine, Tanta University | Recruiting | Tanta | Outside U.S./Canada | 6620010 | Egypt |
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| 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) |
|
| normal saline | Drug | normal saline (2 ml) on the irrigation solution (placebo) |
|
| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| D005839 | Gentamicins |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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