Clinical trial NCT06469125: Anatomic Endoscopic Prostate Enucleation and BICEP Classification
Official title: Multicentric Prospective Evaluation of Bladder Injuries During Morcellation Using BICEP (Bladder Injury Classification During Endoscopic Procedures)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bladder Injury
Prostate Hyperplasia
Keywords: BICEP classification
Anatomic Endoscopic Enucleation of Prostate
Bladder Injury
HoLEP
BiLEP
ThuFLEP
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: Danube University Krems
name: University General Hospital of Heraklion
name: Paracelsus Medical University
name: University of Turin, Italy
name: Menoufia University
name: Acibadem Ankara Hospital
name: Universitätsmedizin Mannheim
name: Martini-Klinik am UKE GmbH
name: Asklepios Kliniken Hamburg GmbH
name: Istanbul Medipol University Hospital
name: Saint Petersburg State University, Russia
name: HM Sanchinarro University Hospital
name: Alexandria University
name: Spital Thurgau AG
name: Medical University of Graz
name: King's College Hospital NHS Trust
name: Sheikh Khalifa Medical City
First posted: 2024-06-21
Enrollment: 250
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 weeks
measure: The impact of different energy sources and morcellation devices on bladder injury
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Postoperative Qmax Increase Following Morcellation in AEEP Operations
timeFrame: 1 month post surgery
measure: Postoperative Improvement in International Prostate Symptom Score (IPSS)
timeFrame: 1 month post surgery
measure: Duration of catheterization
timeFrame: Up to 10 weeks
measure: Length of hospital stay
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University
name: Selçuk Güven, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Istanbul Medipol University Hospital
name: Bülent Erkurt, Prof. Dr.
role: STUDY_CHAIR
affiliation: Necmettin Erbakan University
name: Selim Soytürk, RA
role: PRINCIPAL_INVESTIGATOR
References:
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 experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
citation: 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.
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.1998.12.457.