Urinary Bladder CancerNCT07259798
Histopathological Findings in En-Bloc vs Conventional Transurethral Resection of Bladder Tumors.
A study testing En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop and Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform in people with Urinary Bladder Cancer, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop and Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor diameter of 2-6 cm
- Patients fit for spinal or general anesthesia
Who cannot join
- recurrent bladder tumours.
- concomitant urothelial cancer of the upper urinary tract
- metastatic bladder cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between En-Bloc Transurethral Resection Versus Conventional Transurethral Resection of Urinary Bladder Tumors From 2 to 6 cm in Size, Histopathological Findings.
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.
Read the 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
- Being tested
- En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop, Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform
- Keywords
- TURBT, en bloc TURBT, TCC of the bladder, Histopathological findings
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loopProcedure or surgery
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 platformProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Underwent En bloc Bipolar TURBT | Experimental | Not described Receives: 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 | Not described Receives: Procedure: Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days post TURBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Aug 2024
- Primary completion1 Feb 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Mohammed K Ahmed, Assisstant Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259798
- Sponsor's protocol ID
- FMASU MS429/2024
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31910427Sun 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.
PubMed 38022709
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between En-Bloc Transurethral Resection Versus Conventional Transurethral Resection of Urinary Bladder Tumors From 2 to 6 cm in Size, Histopathological Findings.
- ClinicalTrials.gov ID
- NCT07259798
- Acronym / sponsor ID
- FMASU MS429/2024
- Conditions
- Urinary Bladder Cancer
- Keywords
- TURBT, en bloc TURBT, TCC of the bladder, Histopathological findings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tumor diameter of 2-6 cm
- Patients fit for spinal or general anesthesia
Key exclusion criteria (3 listed)
- recurrent bladder tumours.
- concomitant urothelial cancer of the upper urinary tract
- metastatic bladder cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loopA 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 or surgery | Group A: Underwent En bloc Bipolar TURBT |
| Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platformThe 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. | Procedure or surgery | Group B: Bipolar piecemeal TURBT |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 31910427Yang 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.
- Results publication: PubMed 38022709Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed K Ahmed, Assisstant Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop and Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform in people with Urinary Bladder Cancer, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence of detrusor muscle in histopathologic specimens (time frame: 10 days post TURBT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07259798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.