Health TrialsbyHealthPanel

INTRAOPERATIVE BLADDER INJURY ASSESSMENT IN TURBT USING BICEP

ConditionsBladder (Urothelial, Transitional Cell) CancerTURBTBladder Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNecmettin Erbakan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with incomplete intraoperative data regarding bladder injury assessment

Patients who decline participation, if informed consent is required

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: TURBT PATIENT COHORT1 intervention

Trial outcomes

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.

Time frame
During the surgical procedure (intraoperative)

Secondary outcomes

1

Characteristics of intraoperative bladder injuries

Anatomical location, timing, and severity distribution of intraoperative bladder injuries as classified by the BICEP system.

Time frame
Intraoperative and immediate postoperative period
2

Management of intraoperative bladder injuries according to BICEP grade

Management strategies applied for intraoperative bladder injuries based on BICEP classification, including conservative management, prolonged catheterization, endoscopic intervention, or surgical repair.

Time frame
Intraoperative and immediate postoperative period
3

Postoperative catheter duration

Duration of urinary catheterization following transurethral resection of bladder tumors in relation to BICEP classified intraoperative bladder injuries.

Time frame
From end of surgery until catheter removal, up to 30 days postoperatively
4

Length of hospital stay

Length of hospitalization following transurethral resection of bladder tumors according to the presence and severity of BICEP classified intraoperative bladder injuries.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Necmettin Erbakan University

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Collaborator

Medical University of Graz

Collaborator

Hannover Medical School

Collaborator

King's College London

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: