NCT07259798

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 21, 2025

Last Update Submit

December 3, 2025

Conditions

Urinary Bladder Cancer

Keywords

TURBTen bloc TURBTTCC of the bladderHistopathological findings

Outcome Measures

Primary Outcomes (1)

  • the presence of detrusor muscle in histopathologic specimens

    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

    10 days post TURBT

Study Arms (2)

Group A: Underwent En bloc Bipolar TURBT

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

Interventions

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

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 A: Underwent En bloc Bipolar TURBT
Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platformPROCEDURE

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.

Group B: Bipolar piecemeal TURBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11566, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 31910427RESULT

  • 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.

    PMID: 38022709RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Mohammed K Ahmed, Assisstant Professor

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Urology

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 2, 2025

Study Start

August 1, 2024

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)