NCT07534631

Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bladder Tumor (TURBT)

Interventions

Type	Name	Description
PROCEDURE	Holmium Laser En-Bloc Resection of Bladder Tumor	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.
PROCEDURE	Conventional Transurethral Resection of Bladder Tumor	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.

Timeline

• Start date: 2025-01-05
• Primary completion: 2025-10-05
• Completion: 2026-01-05
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Egypt