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This study is a prospective randomized controlled trial comparing holmium laser en-bloc resection of bladder tumor (HoLERBT) with conventional transurethral resection of bladder tumor (cTURBT) in patients with suspected non-muscle-invasive bladder cancer (NMIBC).
A total of 100 patients will be randomly assigned in a 1:1 ratio to undergo either HoLERBT or cTURBT. The primary outcome is the quality of the pathological specimen, assessed by the presence of detrusor muscle. Secondary outcomes include perioperative complications, operative time, obturator nerve reflex, bladder perforation, positive surgical margins, persistent disease at second-look TURBT, and recurrence rates at 3 and 12 months, as well as recurrence-free survival.
This study aims to evaluate whether HoLERBT provides superior resection quality and improved clinical outcomes compared to conventional TURBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holmium Laser En-Bloc Resection (HoLERBT) | Experimental | Patients in this group will undergo holmium laser en-bloc resection of bladder tumor (HoLERBT). The procedure involves complete tumor excision in a single piece using a holmium laser, allowing improved specimen quality and better hemostasis. |
|
| Conventional TURBT | Active Comparator | Patients in this group will undergo conventional transurethral resection of bladder tumor (cTURBT), performed using standard resection techniques with a monopolar or bipolar resectoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium Laser En-Bloc Resection of Bladder Tumor | Procedure | Holmium laser en-bloc resection of bladder tumor (HoLERBT) is a surgical technique in which the bladder tumor is removed in a single piece using a holmium laser. The procedure allows precise dissection, improved hemostasis, and better preservation of specimen integrity for pathological assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Detrusor Muscle in Resected Specimen | Assessment of the quality of tumor resection based on the presence of detrusor muscle in the histopathological specimen obtained after surgery. | Immediately after surgery (postoperative histopathological assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Complications | Incidence of intraoperative complications including obturator nerve reflex, intraoperative bleeding, and bladder perforation. | During surgery |
| Tumor Recurrence at 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University Hospital | Banī Suwayf | Beni Suef Governorate | 62511 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 5, 2025 | Apr 10, 2026 |
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| Conventional Transurethral Resection of Bladder Tumor | Procedure | Conventional transurethral resection of bladder tumor (cTURBT) is a standard surgical procedure in which the tumor is removed in multiple fragments using a monopolar or bipolar resectoscope. |
|
Incidence of bladder tumor recurrence at 3 months follow-up.
| 3 months after surgery |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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