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Completed

NCT Number: NCT07259798

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

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.

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Key information

Conditions

Urinary Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbasia, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

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

Procedure

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.

Primary outcomes

  1. the presence of detrusor muscle in histopathologic specimens

    Time frame: 10 days post TURBT

    This assessment aims to compare the histopathological outcomes between the tumors obtained from the en bloc bipolar resection versus the conventional method bipolar Trans-Urethral Resection of Bladder Tumor techniques

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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