NCT07259798

Histopathological Findings in En-Bloc vs Conventional Transurethral Resection of Bladder Tumors.

Comparison Between En-Bloc Transurethral Resection Versus Conventional Transurethral Resection of Urinary Bladder Tumors From 2 to 6 cm in Size, Histopathological Findings.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine whether en-bloc TURBT provides superior histopathological quality and clinical outcomes compared to conventional TURBT in medium-sized bladder tumors.

Detailed description

This study is a prospective randomized clinical trial conducted at Ain Shams University to compare en-bloc transurethral resection (ERBT) with conventional transurethral resection (TURBT) for urinary bladder tumors sized 2-6 cm. The primary endpoint is the presence of detrusor muscle in histopathological specimens, while secondary outcomes include bladder perforation, residual disease at second TURBT, margin status, operation time, obturator reflex, and conversion rates. By focusing on specimen integrity and surgical efficacy, the study aims to determine whether en-bloc TURBT provides superior diagnostic accuracy and clinical outcomes compared to the conventional approach.

Conditions

• Urinary Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop	A specialized "flat" resection loop (Karl-Storz En-Bloc Electrode, stainless steel, approximately 24 mm diameter). This loop features a broad, planar configuration with a smooth leading edge designed to dissect beneath the tumor base in a single piece while maintaining an intact specimen-muscle interface and minimizing fragmentation.
PROCEDURE	Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform	The resections were performed with a standard U-shaped cutting loop electrode (Karl-Storz, stainless steel, 24 mm diameter) mounted on a bipolar working element compatible with a 26-Fr continuous-flow resectoscope sheath and a 30-degree Hopkins® rod-lens telescope. The U-shaped loop, characterized by its semi elliptical contour and dual active cutting arms, facilitates sequential layer-by-layer resection of the tumor in multiple fragments, permitting simultaneous coagulation of bleeding vessels.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-02-01
• Completion: 2025-06-01
• First posted: 2025-12-02
• Last updated: 2025-12-10

Locations

1 site across 1 country: Egypt