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A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bipolar Enucleation | Bipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation. |
| |
| Laser Enucleation | Laser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A single working element for bipolar enucleation | Device | Device: A single working element compatible with both bipolar and laser modalities. The bipolar energy will be used for cutting and coagulation during enucleation. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities. | the operative time |
| Safety | intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS). | 1 month |
| Cost Analysis |
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Inclusion Criteria:
Exclusion Criteria:
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the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed K Omar, Assistant professor | Contact | +201066949454 | kimo_81eg@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia Faculty of Medicine | Recruiting | Shibīn al Kawm | Menoufia | 13829 | Egypt |
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| A single working element for laser enucleation | Device | Device: A single working element compatible with both bipolar and laser modalities. Thulium or Holmium laser will be employed for tissue dissection and hemostasis. |
|
Cost of using a single working element vs. standard separate tools for bipolar and laser.
| the operative time |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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