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Safety assessment and oncological results of using laser in the treatment of bladder tumor compared to tumor resection

Safety and oncological outcomes of endoscopic laser enucleation comparing with transurethral resection: A randomized controlled trial - TRB

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-67npwrk
Enrollment
Unknown
Registered
2021-02-05
Start date
2020-01-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Intervention - 50 patients submitted to Holmium Laser Enucleation of Bladder tumors (HoLEBT) and morcellation Controle - 50 patients submitted to Transurethral Ressection of Bladder Tumors (TURBT)

Sponsors

Universidade de Sao Paulo - Instituto do Câncer do Estado de São Paulo (ICESP)
Lead Sponsor
Universidade de Sao Paulo - Instituto do Câncer do Estado de São Paulo (ICESP)
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Volunteers with tumors larger than 3 cm; older than 18 years; able to understand and willing to sign a written informed consent; satisfactory clinical pre operators conditions for surgery

Exclusion criteria

Exclusion criteria: Previous diagnosis of mibc; turbt in the last 5 years; radiological or clinical features of mibc; urethral stenosis; previous intravesical or systemic chemotherapy; previous use of bcg; no clinical conditions for surgery

Design outcomes

Primary

MeasureTime frame
Assess the presence of detrusor muscle in the specimen

Secondary

MeasureTime frame
Assess the rate of recurrence or progression at 3, 6, 9, 12, 15, 18 and 24 months; We will observe the rates of bleeding, perforation, hyponatremia and complete resection at the end of the surgery ;Length of hospital stay, total time of irrigation, clot retention, UTI and other complications after surgery (Clavien-Dindo);To assess the presence of residual tumor in the re-TUR with 30 days

Countries

Brazil

Contacts

Public ContactAlexandre Iscaife

Universidade de Sao Paulo - Instituto do Câncer do Estado de São Paulo (ICESP)

Alexandre.iscaife@hc.fm.usp.br+55 (11) 2661-8086

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 18, 2026