Multicentric Prospective Evaluation of Bladder Injuries During Morcellation Using BICEP (Bladder Injury Classification During Endoscopic Procedures)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The impact of different energy sources and morcellation devices on bladder injury
研究概览
简要总结
The Bladder Injury Classification System for Endoscopic Procedure (BICEP) is designed to provide a systematic framework for categorizing bladder injuries that occur during endoscopic procedures. By standardizing the classification of these injuries, BICEP promotes a more consistent approach to diagnosis, management, and prevention across different urologic interventions. This study aims to validate and implement the BICEP system during morcellation.
This study will:
Validate BICEP by using real-life clinical scenarios to ensure its applicability and effectiveness.
Assess the incidence and types of bladder injuries during morcellation, using the BICEP categorization to standardize injury reporting and enhance treatment protocols.
详细描述
Insufficient knowledge exists about bladder injuries during morcellation, as the existing literature primarily consists of isolated case reports. The Bladder Injury Classification System for Endoscopic Procedures (BICEP) aims to standardize the reporting and management of bladder injuries during endoscopic surgeries.
This study proposes an external validation of the BICEP system through an international, multicenter, prospective observational study. The objectives of this study are fourfold:
Validate the newly developed BICEP classification system with real-life clinical scenarios to ensure its applicability and effectiveness.
Evaluate the incidence and types of bladder injuries during morcellation using the BICEP framework to standardize injury reporting and enhance treatment protocols.
Assess the robustness of BICEP across different departments. Facilitate the adoption of BICEP as a global standard for classifying bladder injuries in endoscopic surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥40
- •ASA (American Society of Anesthesiologists) score ≤4
- •Patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) surgery.
排除标准
- •Patients with neurological disorders that may affect bladder function, such as cerebrovascular stroke or Parkinson's disease.
- •Patients with active urinary tract infection.
- •Patients diagnosed with bladder cancer within the last 2 years.
- •Patients with prostate cancer.
- •Patients who have undergone previous prostate surgery.
结局指标
主要结局
The impact of different energy sources and morcellation devices on bladder injury
时间窗: Up to 24 weeks
The severity of the injury will be assessed using a scoring system ranging from 0 to 4. A score of 0 indicates no injury, while a score of 4 indicates the highest degree of avulsion of part of the bladder. In this system, the severity of the injury increases as the score increases.
Number of Participants with Successful Validation of the Bladder Injury Classification System for Endoscopic Procedure Classification System for Bladder Injuries Occurring During Morcellation in AEEP Operations
时间窗: Up to 24 weeks
Approximately 250 participants will be evaluated using a scoring system ranging from 0 to 4 to assess the severity of the injury. A score of 0 indicates no injury, while a score of 4 indicates extensive avulsion of part of the bladder. In this system, the severity of the injury increases as the score increases.
次要结局
- Postoperative Improvement in International Prostate Symptom Score (IPSS)(1 month post surgery)
- Postoperative Qmax Increase Following Morcellation in AEEP Operations(1 month post surgery)
- Length of hospital stay(Up to 6 weeks)
- Duration of catheterization(Up to 10 weeks)
研究者
Selim Soyturk
Research Assistant
Necmettin Erbakan University