Anatomic Endoscopic Prostate Enucleation and BICEP Classification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-08

Study Completion Date

2025-11-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Injury Prostate Hyperplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Morcellation

Eligibility Criteria

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Inclusion Criteria

* 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.

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.

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes