Anatomic Endoscopic Prostate Enucleation and BICEP Classification

Prostate Hyperplasia Clinical Trial

— BICEP  

Official title:

Multicentric Prospective Evaluation of Bladder Injuries During Morcellation Using BICEP (Bladder Injury Classification During Endoscopic Procedures)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06469125
• Other study ID #: ResCORE-2024-12
• Status: Enrolling by invitation
• Start date: June 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 30, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients aged =40

• ASA (American Society of Anesthesiologists) score =3

• Estimated weight on ultrasound (USG) =40 grams for prostate weight

• Patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) surgery.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bladder Injury
• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Endoscopic Prostate Interventions for Anatomic Enucleation
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul
Turkey	Necmettin Erbakan University	Konya

Sponsors (18)

Lead Sponsor

Collaborator

Necmettin Erbakan University

Acibadem Ankara Hospital, Alexandria University, Asklepios Kliniken Hamburg GmbH, Danube University Krems, HM Sanchinarro University Hospital, Istanbul Medipol University Hospital, King's College Hospital NHS Trust, Martini-Klinik am UKE GmbH, Medical University of Graz, Menoufia University, Paracelsus Medical University, Saint Petersburg State University, Russia, Sheikh Khalifa Medical City, Spital Thurgau AG, Universitätsmedizin Mannheim, University General Hospital of Heraklion, University of Turin, Italy

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 re — View Citation

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 exper — View Citation

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.19 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of BICEP Classification System	Assess the applicability and effectiveness of the newly developed BICEP classification system using real-life clinical scenarios during anatomic endoscopic enucleation of the prostate.This validation will involve evaluating the system's accuracy and reliability in classifying bladder injuries occurring during morcellation.	Up to 24 weeks
Secondary	Incidence and Types of Bladder Injuries	Evaluate the incidence and types of bladder injuries occurring during morcellation using the BICEP classification.This will involve standardizing injury reporting and enhancing treatment protocols based on the classification provided by the BICEP system.	Up to 24 weeks
Secondary	Robustness of BICEP Across Different Departments	The existing BICEP classification in this study evaluates bladder injuries during surgery by considering every layer of the bladder, with the criterion for injury being a part of this classification.; To assess consistency, it is suitable to compare BICEP classifications across different surgeons or urology clinics in different hospitals. This comparison evaluates the similarity of classifications made by different surgeons or clinics on the same patient, thus helping to determine the overall consistency of the system.; As for reliability, it is appropriate to compare BICEP classifications within the same surgeon or urology clinic in the same hospitals. This assessment evaluates how close repeated classifications made by the same surgeon or clinic are to each other, aiding in determining the reliability of the system	Up to 24 weeks

External Links

•   A case of blunt abdominal trauma resulting in significant bladder injury (AAST grade IV)