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

Ain Shams University

Status: Completed

Conditions: Urinary Bladder Cancer

Treatments: Procedure: En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop; Procedure: Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform

Study type: Interventional

Funder types: Other

Identifiers

NCT07259798

FMASU MS429/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tumor diameter of 2-6 cm
• Patients fit for spinal or general anesthesia

Exclusion criteria

• recurrent bladder tumours.
• concomitant urothelial cancer of the upper urinary tract
• metastatic bladder cancer

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group A: Underwent En bloc Bipolar TURBT

Experimental group

Treatment:

Procedure: En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop

Group B: Bipolar piecemeal TURBT

Active Comparator group

Treatment:

Procedure: Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform