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Набор скоро начнётся NCT07396038

INTRAOPERATIVE BLADDER INJURY ASSESSMENT IN TURBT USING BICEP

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care..
Кому может быть актуально
Состояния в реестре: Bladder (Urothelial, Transitional Cell) Cancer, TURBT, Bladder Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Intraoperative Bladder Injuries During Transurethral Resection of Bladder Tumors Using the BICEP Classification (BICEP on TURBT)

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Intraoperative bladder injury severity assessed using the BICEP classification [Срок оценки: During the surgical procedure (intraoperative)]
Вторичные конечные точки (7)
  • Characteristics of intraoperative bladder injuries [Срок оценки: Intraoperative and immediate postoperative period]
  • Management of intraoperative bladder injuries according to BICEP grade [Срок оценки: Intraoperative and immediate postoperative period]
  • Postoperative catheter duration [Срок оценки: From end of surgery until catheter removal, up to 30 days postoperatively]
  • Length of hospital stay [Срок оценки: From end of surgery until hospital discharge during index hospitalization (up to 30 days)]
  • Readmission within 30 days [Срок оценки: 30 days postoperative]
  • Re-intervention within 30 days [Срок оценки: 30 days postoperative]
  • Postoperative complications [Срок оценки: 30 days postoperative]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Patients with incomplete intraoperative data regarding bladder injury assessment
  • Patients who decline participation, if informed consent is required

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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/s00345-022-04 PMID 35665840
  • Akgul 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 Invo PMID 39327217

Идентификаторы

NCT: NCT07396038 · ReScore26-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗