INTRAOPERATIVE BLADDER INJURY ASSESSMENT IN TURBT USING BICEP

NCT07396038 | Not Yet Recruiting

• 1 other identifier: ReScore26-1
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Transurethral resection of bladder tumor (TURBT) is the cornerstone procedure in the diagnosis and treatment of bladder cancer but is associated with a spectrum of intraoperative bladder injuries ranging from minor mucosal tears to major perforations. Currently, there is no standardized intraoperative classification system specifically designed to grade and report these injuries during TURBT. This study aims to apply the Bladder Injury Classification System for Endoscopic Procedures (BICEP) to TURBT in order to systematically classify intraoperative bladder injuries, evaluate their management, and explore their association with perioperative and early postoperative outcomes.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer; TURBT; Bladder Injury

Keywords

Transurethral resection of bladder tumor; Bladder perforation; Bladder cancer surgery; Bladder injury classification; Ureteral orifice injury; Endoscopic bladder surgery complications

Outcome Measures

Primary Outcomes (1)

• Intraoperative bladder injury severity assessed using the BICEP classification

  Intraoperative bladder injuries occurring during transurethral resection of bladder tumors are classified and graded using the Bladder Injury Classification System for Endoscopic Procedures (BICEP), an ordinal scale ranging from 0 (no injury) to 4 (most severe injury requiring surgical intervention). Higher scores indicate greater injury severity.

  During the surgical procedure (intraoperative)

Secondary Outcomes (7)

• Characteristics of intraoperative bladder injuries

  Intraoperative and immediate postoperative period

• Management of intraoperative bladder injuries according to BICEP grade

  Intraoperative and immediate postoperative period

• Postoperative catheter duration

  From end of surgery until catheter removal, up to 30 days postoperatively

• Length of hospital stay

  From end of surgery until hospital discharge during index hospitalization (up to 30 days)

• Readmission within 30 days

  30 days postoperative

Study Arms (1)

TURBT PATIENT COHORT

Patients undergoing transurethral resection of bladder tumor for diagnostic, staging, primary treatment, or re-resection purposes. All participants are evaluated intraoperatively for the presence and severity of bladder injuries using a standardized endoscopic injury classification system, with subsequent recording of perioperative and early postoperative outcomes.

Other: No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.

Interventions

No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care. OTHER

No intervention is assigned as part of this observational study. All procedures are performed as part of routine clinical care.

TURBT PATIENT COHORT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing transurethral resection of bladder tumors at participating centers. Participants are identified from consecutive cases in which intraoperative bladder injury assessment is performed and recorded using a standardized classification approach during the procedure.

You may qualify if:

• Adult patients aged 18 years or older
• Patients undergoing transurethral resection of bladder tumor
• Procedures performed for primary resection, re-resection, diagnostic, or staging purposes

You may not qualify if:

• Patients with incomplete intraoperative data regarding bladder injury assessment
• Patients who decline participation, if informed consent is required

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• University Hospital Southampton NHS Foundation Trust: collaborator
• Medical University of Graz: collaborator
• Hannover Medical School: collaborator
• King's College London: collaborator

Related Publications (2)

• 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.

  PMID: 35665840 BACKGROUND

• Akgul B, Tozsin A, Tokas T, Micali S, Herrmann T, Bianchi G, Fiori C, Altinkaya N, Ortner G, Knoll T, Lehrich K, Bohme A, Gadzhiev N, Omar M, Kartalas Goumas I, Romero Otero J, Aydin A, Lusuardi L, Netsch C, Khan A, Greco F, Dasgupta P, Tunc L, Rassweiler J, Serdar Gozen A, Ahmed K, Guven S. Development of a Bladder Injury Classification System for Endoscopic Procedures: A Mixed-methods Study Involving Expert Consensus and Validation. Eur Urol Focus. 2025 Jan;11(1):126-135. doi: 10.1016/j.euf.2024.09.004. Epub 2024 Sep 25.

  PMID: 39327217 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Selçuk Güven, Prof

  Necmettin Erbakan University

  STUDY CHAIR

Central Study Contacts

Selim Soytürk, MD

CONTACT

+905077299193; selim.soyturk@erbakan.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist / Coordinating Investigator

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 9, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be available beginning 12 months after publication of the primary results manuscript and will remain available for a minimum of 5 years thereafter.
• Access Criteria: only qualified researchers with a methodologically sound proposal will be granted access. Requests must be reviewed and approved by the principal investigator and require completion of a data-use agreement. Access will be provided in de-identified format only and delivered via secure, password-protected electronic transfer. No direct identifiers or protected health information will be shared.