Clinical trial · Observational
INTRAOPERATIVE BLADDER INJURY ASSESSMENT IN TURBT USING BICEP
Evaluation of Intraoperative Bladder Injuries During Transurethral Resection of Bladder Tumors Using the BICEP Classification (BICEP on TURBT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Injury | — | UNRESOLVED | — |
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| TURBT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TURBT PATIENT COHORT
- description
- 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.
- interventionNames
- Other: No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.
Primary outcomes (1)
- measure
- Intraoperative bladder injury severity assessed using the BICEP classification
- timeFrame
- During the surgical procedure (intraoperative)
- description
- 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.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with incomplete intraoperative data regarding bladder injury assessment * Patients who decline participation, if informed consent is required
References
Publications (2)
- BACKGROUNDBreda 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. PMID 35665840
- BACKGROUNDAkgul 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. PMID 39327217