NCT07396038

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Bladder (Urothelial, Transitional Cell) Cancer
• TURBT
• Bladder Injury

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-12-30
• Completion: 2027-03-30
• First posted: 2026-02-09
• Last updated: 2026-02-09