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Safety and oncologic outcomes of endoscopic resection of bladder tumor with holmium laser in comparision with the monopolar turb: a prospective and randomized analysys

Abstract

The urothelial bladder carcinoma is the second most common urologic neoplasm and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with TURB (Transurethral Bladder Resection). However, the classical TURB with electric power (monopolar or bipolar) fragments the tumor, burning it to the own muscular layer causing artifacts that undermine the histopathological analysis.The modern laser technologies have emerged as an alternative to classical TURB using the en-bloc tumor enucleation technique (HoLERBT). Thus, it acts on its pedicle with the laser in order to enucleate the whole tumor and intact, without fragmentation or fulguration as it occurs in the TURB.The purpose of laser use is to improve the quality of resection, decrease intra and perioperative complications, avoid re-TURB and reduce recurrence rates at the resection site and at a distance.Objective: The purpose of this study is to evaluate the use of holmium laser for enucleation of large tumors (> 3 cm), reducing complications and costs and improving muscle layer samples, reducing the need for new approaches.Methods. Prospective randomized clinical trial with a group of 50 patients for holmium enucleation of bladder tumor with (HoLERBT) and 50 patients in the monopolar TURB group (control). All patients will undergo a new procedure between 30-60 days after the first one (monopolar TURB).The laser group will be operated by an experienced surgeon with more than 100 cases of prostate enucleation. The monopolar TRUB group will be operated by the institution's assistant group, ie, urologists with more than 2 years of experience in the field and more than 50 surgeries performed.Pathological analysis - Samples will be sent to the Laboratory of Pathology of the Cancer Institute of Sao Paulo (ICESP) and analyzed by uropathologist with extensive experience in the analysis of bladder tumors.The patients will be followed for 2 years to evaluate tumor recurrence and progression in both groups.Inclusion criteria: bladder tumors with more than 3cm in the largest diameter measured by ultrasound, CT or MRI performed at the maximum 3 months of surgery, age between 50 and 80 years, there is no upper limit since the patient has surgical conditions.Exclusion criteria: Previous diagnosis of invasive muscle bladder tumor, urethral stenosis, systemic or intra-vesical chemotherapy or previous radiotherapy. All patients will sign the attached free and informed consent form. (AU)

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