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| Name | Class |
|---|---|
| Theodor Bilharz Research Institute | OTHER |
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To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 gm)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| holmium laser enucleation of the prostate | Active Comparator | holmium laser enucleation of the prostate (HoLEP) |
|
| bipolar resection of the prostate | Active Comparator | bipolar resection of the prostate (BPEP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| holmium laser enucleation of the prostate | Procedure | cystoscopic transurethral enucleation of the prostate using Holmium laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin drop postoperatively (gm/dL) | change in hemoglobin concentration postoperatively vs preoperatively | within two hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| operative duration in minutes | operative duration | Time lapsed during surgery |
| Hospital stay | Hospitalisation starting from day of surgery till the day of discharge from Hospital in days |
| Measure | Description | Time Frame |
|---|---|---|
| complications (percent) | All complications | Three years |
| International prostate symptom score (IPSS) | an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mamdouh A Roshdy, M.D | Theodor Bilharz research institue | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | 12222 | Egypt | |||
| Theodor Bilharz research institute |
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|
| Bipolar resection of the prostate | Procedure | cystoscopic transurethral resection of the prostate using bipolar energy |
|
|
| From time of randomisation up to last day of admission in hospital (in days) up to 30 days |
| blood transfusion | rate of blood transfusion | during surgery and hospitalisation up to 10 days |
| Three years |
| Quality of life (QoL) | section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst) | Three years |
| flowmetry | rate of flow (ml urine) per second | Three years |
| Giza |
| 12111 |
| Egypt |