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The aim of this prospective study is to evaluate the learning curve and functional outcomes of Thulium Fiber Laser Enucleation of the Prostate (TfLEP) performed by a single surgeon. The study focuses on surgical efficiency, safety (complication rates), and the improvement of lower urinary tract symptoms (LUTS) and quality of life over a 12-month follow-up period.
Thulium Fiber Laser (TFL) is an emerging technology in the field of laser prostatectomy. While Holmium Laser Enucleation (HoLEP) is well-established, the learning curve and long-term functional stability of TFL need further prospective validation. This study will involve the first [Insert Number, e.g., 100] consecutive cases of TfLEP. The "Learning Curve" will be analyzed using Cumulative Sum (CUSUM) analysis of enucleation efficiency and operative time. Functional outcomes will be assessed via IPSS, Qmax, and IIEF-5 scores at baseline and post-operative intervals (1, 3, and 12 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Fiber Laser Enucleation of the Prostate (ThuFlEP) Group | Experimental | All patients in this study group will undergo Thulium Fiber Laser Enucleation of the Prostate (TfLEP) for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH). The surgical procedure involves using a 60-watt Thulium Fiber Laser (TFL) system to enucleate the prostatic adenoma in a retrograde or antegrade fashion. Following enucleation, the adenoma is removed from the bladder using a mechanical morcellator. The study will monitor the surgeon's performance from the first consecutive case to evaluate the learning curve (measured by operative efficiency) and assess functional outcomes (IPSS, Qmax, and Quality of Life) at post-operative intervals of 1, 3, and 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium Fiber Laser (TFL) Enucleation | Device | Surgical enucleation of the prostate using TFL technology to achieve complete removal of the transition zone adenoma, aiming for symptomatic relief and improvement in urinary flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Learning Curve Competency | The point at which the surgeon achieves a stable enucleation efficiency (grams of tissue/minute) and a significant reduction in operative time. | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Gaziantep, | Gaziantep | Gazi̇antep | 27310 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| D052801 |
| Male Urogenital Diseases |