Bladder (Urothelial, Transitional Cell) CancerBICEP in TURBTNCT07396038
INTRAOPERATIVE BLADDER INJURY ASSESSMENT IN TURBT USING BICEP
An observational study of Bladder (Urothelial, Transitional Cell) Cancer and TURBT, run by Necmettin Erbakan University.
Trial summary
Transurethral resection of bladder tumor (TURBT) is the cornerstone procedure in the diagnosis and treatment of bladder cancer but is associated with a spectrum of intraoperative bladder injuries ranging from minor mucosal tears to major perforations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, TURBT, Bladder Injury
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 30 Mar 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of adult patients undergoing transurethral resection of bladder tumors at participating centers. Participants are identified from consecutive cases in which intraoperative bladder injury assessment is performed and recorded using a standardized classification approach during the procedure.
Who may be able to join
- Adult patients aged 18 years or older
- Patients undergoing transurethral resection of bladder tumor
- Procedures performed for primary resection, re-resection, diagnostic, or staging purposes
Who cannot join
- Patients with incomplete intraoperative data regarding bladder injury assessment
- Patients who decline participation, if informed consent is required
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Intraoperative Bladder Injuries During Transurethral Resection of Bladder Tumors Using the BICEP Classification (BICEP on TURBT)
Transurethral resection of bladder tumor (TURBT) is the cornerstone procedure in the diagnosis and treatment of bladder cancer but is associated with a spectrum of intraoperative bladder injuries ranging from minor mucosal tears to major perforations. Currently, there is no standardized intraoperative classification system specifically designed to grade and report these injuries during TURBT.
This study aims to apply the Bladder Injury Classification System for Endoscopic Procedures (BICEP) to TURBT in order to systematically classify intraoperative bladder injuries, evaluate their management, and explore their association with perioperative and early postoperative outcomes.
Read the detailed description
Transurethral resection of bladder tumors (TURBT) is a fundamental endourological procedure for the diagnosis, staging, and initial management of bladder cancer. Despite its widespread use and standardized oncological objectives, TURBT is associated with a broad spectrum of intraoperative bladder injuries, ranging from minor mucosal lesions to major bladder perforations or ureteral orifice injuries. Currently, intraoperative bladder injuries during TURBT are inconsistently defined and reported, often being retrospectively captured only through postoperative complication grading systems, which limits objective comparison between techniques, surgeons, and centers.
This study is designed as an observational patient registry aiming to systematically evaluate intraoperative bladder injuries occurring during TURBT using the Bladder Injury Classification System for Endoscopic Procedures (BICEP). The BICEP classification is an anatomically based intraoperative grading system that categorizes bladder injuries according to depth, severity, and required management, allowing standardized real-time documentation of endoscopic injuries. By applying this framework to TURBT, the registry seeks to establish a reproducible and clinically meaningful method for injury reporting in oncologic endourology.
The registry will prospectively collect perioperative data from patients undergoing TURBT, including tumor characteristics, operative setting, energy modality, resection technique, intraoperative events such as obturator reflex, and bleeding severity. Intraoperative bladder injuries will be classified using the predefined BICEP categories, and injury timing, anatomical location, confirmation methods, and management strategies will be recorded in a structured manner. Postoperative clinical course data will be captured to allow assessment of early outcomes and short-term clinical impact.
This registry is implemented using a standardized electronic data capture system with predefined variable definitions and structured fields. Data quality is ensured through built-in range checks, mandatory fields for key variables, and internal consistency rules to minimize incomplete or conflicting entries. A detailed data dictionary defines each variable, its clinical meaning, coding structure, and acceptable value ranges to ensure uniform interpretation across participating centers. Source data for registry entries are derived from routine clinical documentation, including operative reports, anesthesia records, and postoperative follow-up notes.
Participating centers are instructed to enter consecutive eligible cases to reduce selection bias and improve representativeness. Periodic data reviews are planned to assess completeness, logical consistency, and adherence to registry definitions. Data validation procedures include cross-checks between related variables (for example, injury grade and management strategy) to identify discrepancies. The registry is designed to be expandable, allowing future linkage with additional outcomes or long-term oncological follow-up modules if required.
Sample size is not fixed a priori, as the registry is designed to capture real-world practice patterns and complication profiles across centers. Accrual will continue until a sufficient number of cases is obtained to allow meaningful descriptive and comparative analyses of injury patterns and associated perioperative factors. Missing data will be handled using predefined categories (unknown, not applicable) and will be reported transparently in analyses.
Statistical analysis will primarily focus on descriptive statistics to characterize injury incidence and severity, followed by exploratory analyses evaluating associations between intraoperative bladder injury grades and perioperative variables or early postoperative outcomes. Analytical methods will be aligned with the observational nature of the registry and hypothesis-generating intent of the study.
By establishing a structured and standardized registry for intraoperative bladder injuries during TURBT, this study aims to improve the quality of complication reporting, facilitate comparison between surgical techniques and energy modalities, and provide a foundation for future prospective validation studies and quality improvement initiatives in endourological oncology.
- Being tested
- No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.
- Keywords
- Transurethral resection of bladder tumor, Bladder perforation, Bladder cancer surgery, Bladder injury classification, Ureteral orifice injury, Endoscopic bladder surgery complications
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.Other
No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| TURBT PATIENT COHORT | Patients undergoing transurethral resection of bladder tumor for diagnostic, staging, primary treatment, or re-resection purposes. All participants are evaluated intraoperatively for the presence and severity of bladder injuries using a standardized endoscopic injury classification system, with subsequent recording of perioperative and early postoperative outcomes. Receives: Other: No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bladder injury severity assessed using the BICEP classification
Intraoperative bladder injuries occurring during transurethral resection of bladder tumors are classified and graded using the Bladder Injury Classification System for Endoscopic Procedures (BICEP), an ordinal scale ranging from 0 (no injury) to 4 (most severe injury requiring surgical intervention). Higher scores indicate greater injury severity.
Measured: During the surgical procedure (intraoperative)
Secondary outcomes (7)
Characteristics of intraoperative bladder injuries
Anatomical location, timing, and severity distribution of intraoperative bladder injuries as classified by the BICEP system.
Measured: Intraoperative and immediate postoperative period
Management of intraoperative bladder injuries according to BICEP grade
Management strategies applied for intraoperative bladder injuries based on BICEP classification, including conservative management, prolonged catheterization, endoscopic intervention, or surgical repair.
Measured: Intraoperative and immediate postoperative period
Postoperative catheter duration
Duration of urinary catheterization following transurethral resection of bladder tumors in relation to BICEP classified intraoperative bladder injuries.
Measured: From end of surgery until catheter removal, up to 30 days postoperatively
Length of hospital stay
Length of hospitalization following transurethral resection of bladder tumors according to the presence and severity of BICEP classified intraoperative bladder injuries.
Measured: From end of surgery until hospital discharge during index hospitalization (up to 30 days)
Readmission within 30 days
Unplanned hospital readmission for any cause within 30 days after transurethral resection of bladder tumors in patients with and without BICEP-classified intraoperative bladder injuries.
Measured: 30 days postoperative
Re-intervention within 30 days
Additional endoscopic or surgical interventions required within 30 days following transurethral resection of bladder tumors in relation to BICEP classified intraoperative bladder injuries.
Measured: 30 days postoperative
Postoperative complications
Postoperative complications graded according to the Clavien Dindo classification system and analyzed in relation to BICEP classified intraoperative bladder injuries.
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
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 Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, Medical University of Graz, Hannover Medical School, King's College London
- Responsible party
- Principal investigator, Selim Soyturk, Necmettin Erbakan University
- Investigators
- Selçuk Güven, Prof, Study chair, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396038
- Sponsor's protocol ID
- ReScore26-1
- Acronym
- BICEP in TURBT
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available upon reasonable request for research purposes. Data will be shared following local ethics committee approval and execution of a data-use agreement. No direct patient identifiers will be shared. Data will include demographic variables, baseline assessments, operative details, postoperative outcomes, and follow-up measures collected in the registry.
Publications
Breda A, Gallioli A, Diana P, Fontana M, Territo A, Gaya JM, Rodriguez-Faba O, Huguet J, Piana A, Verri P, Baboudjian M, Aumatell J, Algaba F, Palou J. The DEpth of Endoscopic Perforation scale to assess intraoperative perforations during transurethral resection of bladder tumor: subgroup analysis of a randomized controlled trial. World J Urol. 2023 Oct;41(10):2583-2589. doi: 10.1007/s00345-022-04052-w. Epub 2022 Jun 4.
PubMed 35665840Akgul B, Tozsin A, Tokas T, Micali S, Herrmann T, Bianchi G, Fiori C, Altinkaya N, Ortner G, Knoll T, Lehrich K, Bohme A, Gadzhiev N, Omar M, Kartalas Goumas I, Romero Otero J, Aydin A, Lusuardi L, Netsch C, Khan A, Greco F, Dasgupta P, Tunc L, Rassweiler J, Serdar Gozen A, Ahmed K, Guven S. Development of a Bladder Injury Classification System for Endoscopic Procedures: A Mixed-methods Study Involving Expert Consensus and Validation. Eur Urol Focus. 2025 Jan;11(1):126-135. doi: 10.1016/j.euf.2024.09.004. Epub 2024 Sep 25.
PubMed 39327217
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Bladder Injuries During Transurethral Resection of Bladder Tumors Using the BICEP Classification (BICEP on TURBT)
- ClinicalTrials.gov ID
- NCT07396038
- Acronym / sponsor ID
- BICEP in TURBT / ReScore26-1
- Keywords
- Transurethral resection of bladder tumor, Bladder perforation, Bladder cancer surgery, Bladder injury classification, Ureteral orifice injury, Endoscopic bladder surgery complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, Medical University of Graz, Hannover Medical School, King's College London
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
Transurethral resection of bladder tumor (TURBT) is the cornerstone procedure in the diagnosis and treatment of bladder cancer but is associated with a spectrum of intraoperative bladder injuries ranging from minor mucosal tears to major perforations. Currently, there is no standardized intraoperative classification system specifically designed to grade and report these injuries during TURBT.
This study aims to apply the Bladder Injury Classification System for Endoscopic Procedures (BICEP) to TURBT in order to systematically classify intraoperative bladder injuries, evaluate their management, and explore their association with perioperative and early postoperative outcomes.
Detailed description
Transurethral resection of bladder tumors (TURBT) is a fundamental endourological procedure for the diagnosis, staging, and initial management of bladder cancer. Despite its widespread use and standardized oncological objectives, TURBT is associated with a broad spectrum of intraoperative bladder injuries, ranging from minor mucosal lesions to major bladder perforations or ureteral orifice injuries. Currently, intraoperative bladder injuries during TURBT are inconsistently defined and reported, often being retrospectively captured only through postoperative complication grading systems, which limits objective comparison between techniques, surgeons, and centers.
This study is designed as an observational patient registry aiming to systematically evaluate intraoperative bladder injuries occurring during TURBT using the Bladder Injury Classification System for Endoscopic Procedures (BICEP). The BICEP classification is an anatomically based intraoperative grading system that categorizes bladder injuries according to depth, severity, and required management, allowing standardized real-time documentation of endoscopic injuries. By applying this framework to TURBT, the registry seeks to establish a reproducible and clinically meaningful method for injury reporting in oncologic endourology.
The registry will prospectively collect perioperative data from patients undergoing TURBT, including tumor characteristics, operative setting, energy modality, resection technique, intraoperative events such as obturator reflex, and bleeding severity. Intraoperative bladder injuries will be classified using the predefined BICEP categories, and injury timing, anatomical location, confirmation methods, and management strategies will be recorded in a structured manner. Postoperative clinical course data will be captured to allow assessment of early outcomes and short-term clinical impact.
This registry is implemented using a standardized electronic data capture system with predefined variable definitions and structured fields. Data quality is ensured through built-in range checks, mandatory fields for key variables, and internal consistency rules to minimize incomplete or conflicting entries. A detailed data dictionary defines each variable, its clinical meaning, coding structure, and acceptable value ranges to ensure uniform interpretation across participating centers. Source data for registry entries are derived from routine clinical documentation, including operative reports, anesthesia records, and postoperative follow-up notes.
Participating centers are instructed to enter consecutive eligible cases to reduce selection bias and improve representativeness. Periodic data reviews are planned to assess completeness, logical consistency, and adherence to registry definitions. Data validation procedures include cross-checks between related variables (for example, injury grade and management strategy) to identify discrepancies. The registry is designed to be expandable, allowing future linkage with additional outcomes or long-term oncological follow-up modules if required.
Sample size is not fixed a priori, as the registry is designed to capture real-world practice patterns and complication profiles across centers. Accrual will continue until a sufficient number of cases is obtained to allow meaningful descriptive and comparative analyses of injury patterns and associated perioperative factors. Missing data will be handled using predefined categories (unknown, not applicable) and will be reported transparently in analyses.
Statistical analysis will primarily focus on descriptive statistics to characterize injury incidence and severity, followed by exploratory analyses evaluating associations between intraoperative bladder injury grades and perioperative variables or early postoperative outcomes. Analytical methods will be aligned with the observational nature of the registry and hypothesis-generating intent of the study.
By establishing a structured and standardized registry for intraoperative bladder injuries during TURBT, this study aims to improve the quality of complication reporting, facilitate comparison between surgical techniques and energy modalities, and provide a foundation for future prospective validation studies and quality improvement initiatives in endourological oncology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TURBT PATIENT COHORT | – | Other: No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.Patients undergoing transurethral resection of bladder tumor for diagnostic, staging, primary treatment, or re-resection purposes. All participants are evaluated intraoperatively for the presence and severity of bladder injuries using a standardized endoscopic injury classification system, with subsequent recording of perioperative and early postoperative outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing transurethral resection of bladder tumors at participating centers. Participants are identified from consecutive cases in which intraoperative bladder injury assessment is performed and recorded using a standardized classification approach during the procedure.
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older
- Patients undergoing transurethral resection of bladder tumor
- Procedures performed for primary resection, re-resection, diagnostic, or staging purposes
Key exclusion criteria (2 listed)
- Patients with incomplete intraoperative data regarding bladder injury assessment
- Patients who decline participation, if informed consent is required
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 |
|---|---|---|
| No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care. | Other | TURBT PATIENT COHORT |
Primary outcome
Intraoperative bladder injury severity assessed using the BICEP classification
Time frame: During the surgical procedure (intraoperative)
Intraoperative bladder injuries occurring during transurethral resection of bladder tumors are classified and graded using the Bladder Injury Classification System for Endoscopic Procedures (BICEP), an ordinal scale ranging from 0 (no injury) to 4 (most severe injury requiring surgical intervention). Higher scores indicate greater injury severity.
7 secondary outcomes
Characteristics of intraoperative bladder injuries
Time frame: Intraoperative and immediate postoperative period
Management of intraoperative bladder injuries according to BICEP grade
Time frame: Intraoperative and immediate postoperative period
Postoperative catheter duration
Time frame: From end of surgery until catheter removal, up to 30 days postoperatively
Length of hospital stay
Time frame: From end of surgery until hospital discharge during index hospitalization (up to 30 days)
Readmission within 30 days
Time frame: 30 days postoperative
Re-intervention within 30 days
Time frame: 30 days postoperative
Postoperative complications
Time frame: 30 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 35665840Breda A, Gallioli A, Diana P, Fontana M, Territo A, Gaya JM, Rodriguez-Faba O, Huguet J, Piana A, Verri P, Baboudjian M, Aumatell J, Algaba F, Palou J. The DEpth of Endoscopic Perforation scale to assess intraoperative perforations during transurethral resection of bladder tumor: subgroup analysis of a randomized controlled trial. World J Urol. 2023 Oct;41(10):2583-2589. doi: 10.1007/s00345-022-04052-w. Epub 2022 Jun 4.
- Background: PubMed 39327217Akgul B, Tozsin A, Tokas T, Micali S, Herrmann T, Bianchi G, Fiori C, Altinkaya N, Ortner G, Knoll T, Lehrich K, Bohme A, Gadzhiev N, Omar M, Kartalas Goumas I, Romero Otero J, Aydin A, Lusuardi L, Netsch C, Khan A, Greco F, Dasgupta P, Tunc L, Rassweiler J, Serdar Gozen A, Ahmed K, Guven S. Development of a Bladder Injury Classification System for Endoscopic Procedures: A Mixed-methods Study Involving Expert Consensus and Validation. Eur Urol Focus. 2025 Jan;11(1):126-135. doi: 10.1016/j.euf.2024.09.004. Epub 2024 Sep 25.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available upon reasonable request for research purposes. Data will be shared following local ethics committee approval and execution of a data-use agreement. No direct patient identifiers will be shared. Data will include demographic variables, baseline assessments, operative details, postoperative outcomes, and follow-up measures collected in the registry.
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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.
Selçuk Güven, Prof study chair
Necmettin Erbakan University
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder (Urothelial, Transitional Cell) Cancer and TURBT, run by Necmettin Erbakan University.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selim Soytürk, MD (+905077299193, selim.soyturk@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bladder injury severity assessed using the BICEP classification (time frame: During the surgical procedure (intraoperative)). 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 NCT07396038, 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 9 Feb 2026.