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| Name | Class |
|---|---|
| Danube University Krems | OTHER |
| University General Hospital of Heraklion | OTHER |
| Paracelsus Medical University | OTHER |
| University of Turin, Italy |
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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.
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.
Through this study, the validity of BICEP will be confirmed and the bladder injuries occurring during morcellation after AEEP will be examined.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Prostate Interventions for Anatomic Enucleation | Procedure | The intervention in this study involves performing anatomic endoscopic enucleation of the prostate (AEEP) using different energy sources. Following the enucleation, the resected prostate tissue will be morcellated within the bladder using various morcellators to remove the enlarged prostate tissue minimally invasively. The process will also involve evaluating and categorizing any resulting bladder injuries using the BICEP classification system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Up to 24 weeks |
| The impact of different energy sources and morcellation devices on bladder injury | 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. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Qmax Increase Following Morcellation in AEEP Operations | Assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec | 1 month post surgery |
| Postoperative Improvement in International Prostate Symptom Score (IPSS) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will include adult patients undergoing AEEP surgery. The presence of bladder injuries during the operation will be assessed according to the BICEP classification, and any potential injuries will be recorded.
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| Name | Affiliation | Role |
|---|---|---|
| Selçuk Güven, Prof. Dr. | Necmettin Erbakan University | Study Director |
| Bülent Erkurt, Prof. Dr. | Istanbul Medipol University Hospital | Study Chair |
| Selim Soytürk, RA | Necmettin Erbakan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necmettin Erbakan University | Konya | Konya | 42250 | Turkey (Türkiye) | ||
| Istanbul Medipol University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638912 | Result | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. | |
| 35665840 |
| Label | URL |
|---|---|
| A case of blunt abdominal trauma resulting in significant bladder injury (AAST grade IV) | View source |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069577 | Morcellation |
| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Menoufia University | OTHER |
| Acibadem Ankara Hospital | OTHER |
| Universitätsmedizin Mannheim | OTHER |
| Martini-Klinik am UKE GmbH | OTHER |
| Asklepios Kliniken Hamburg GmbH | OTHER |
| Istanbul Medipol University Hospital | OTHER |
| Saint Petersburg State University, Russia | OTHER |
| HM Sanchinarro University Hospital | OTHER |
| Alexandria University | OTHER |
| Spital Thurgau AG | OTHER |
| Medical University of Graz | OTHER |
| King's College Hospital NHS Trust | OTHER |
| Sheikh Khalifa Medical City | OTHER |
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The IPSS form will be filled out for calculation. Scores of 0-7 indicate mild symptoms, 8-19 indicate moderate symptoms, and 20-35 indicate severe symptoms. |
| 1 month post surgery |
| Duration of catheterization | The duration of catheterization post-operation will be calculated in days. | Up to 10 weeks |
| Length of hospital stay | The duration of hospital stay post-operation will be calculated in days. | Up to 6 weeks |
| Istanbul |
| Turkey (Türkiye) |
| 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. |
| 9847070 | Result | Gilling PJ, Kennett K, Das AK, Thompson D, Fraundorfer MR. Holmium laser enucleation of the prostate (HoLEP) combined with transurethral tissue morcellation: an update on the early clinical experience. J Endourol. 1998 Oct;12(5):457-9. doi: 10.1089/end.1998.12.457. |
| 41685659 | Derived | Soyturk S, Mateos FL, Sonmez G, Ortner G, Torres D, Tozsin A, Barlas IS, Turan A, Rechner R, Ferretti S, Erkurt B, Karabulut I, Sonmez MG, Kactan MC, Akdere H, Balasar M, Gadzhiev N, Somani B, Tunc L, Otero JR, Herrmann T, Guven S. Bladder injury in anatomical endoscopic enucleation of the prostate and morcellation using the Bladder Injury Classification for Endoscopic Procedures: a European Association of Urology endourology prospective study. BJU Int. 2026 May;137(5):797-804. doi: 10.1111/bju.70170. Epub 2026 Feb 13. |
| D052801 |
| Male Urogenital Diseases |