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

NCT ID: NCT07259798

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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

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Urinary Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A: Underwent En bloc Bipolar TURBT

Group Type EXPERIMENTAL

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

Intervention Type 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.

Group B: Bipolar piecemeal TURBT

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Younan Ramsis

Lecturer of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed K Ahmed, Assisstant Professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Ain Shams University

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

References

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Yang H, Lin J, Gao P, He Z, Kuang X, Li X, Fu H, Du D. Is the En Bloc Transurethral Resection More Effective than Conventional Transurethral Resection for Non-Muscle-Invasive Bladder Cancer? A Systematic Review and Meta-Analysis. Urol Int. 2020;104(5-6):402-409. doi: 10.1159/000503734. Epub 2020 Jan 7.

Reference Type RESULT
PMID: 31910427 (View on PubMed)

Sun S, Wang H, Zhang X, Chen G. Transurethral Resection of Bladder Tumor: Novel Techniques in a New Era. Bladder (San Franc). 2023 Nov 9;10:e21200009. doi: 10.14440/bladder.2023.865. eCollection 2023.

Reference Type RESULT
PMID: 38022709 (View on PubMed)

Other Identifiers

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FMASU MS429/2024

Identifier Type: -

Identifier Source: org_study_id

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