Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

En bloc transurethral resection of the bladder

Conventional transurethral resection of the bladder

En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy

En bloc transurethral resection of bladder tumor (TURBT)

Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

Conventional TURBT

Andrea Gallioli, MD

INTRODUCTION Bladder tumor is the second most common neoplasm in the genitourinary tract. Most cases of ex novo diagnosis of bladder cancers are present as non-invasive muscle tumors, which are treatable through endourological procedures. The current standard is based on conventional transurethral resection of bladder tumor, although high rates of recurrence have been reported following resection of the primary tumor. Given the importance of a correct initial diagnosis in these cases, en bloc transurethral resection has developed over the past 2 decades. This technique was born, according to the literature, with 3 main objectives: to improve the quality of the surgical piece for its anatomopathological reading, reduce the rate of postoperative complications and reduce the rate of relapses in the surgical bed. This technique is used as a common practice of tumor resection in other centers and has been shown in multiple publications that it does not increase surgical risk or negatively affect cancer results.

OBJECTIVE The objective of our study is to compare feasibility, perioperative complication rate, accuracy of staging and recurrence/progression rates when performing en bloc resection by means of different energies: monopolar, bipolar and laser energy.

MATERIAL AND METHODS Between April 2018 and June 2021, a prospective randomized study will be conducted including patients undergoing a transurethral resection of initial or recurrent bladder tumor, either unifocal or multifocal. Patients with tumors less than 3 cm and with less than 3 tumors shall be included if multiple. Patients with more than 3 tumors or tumors over 3cm, those with evidence of invasive muscle tumor(cT2) or those with evidence of remote metastasis, whether lymphatic or organic, will be excluded.

Patients will be randomized into two groups:

* Group 1 (test): en bloc resection (n-180). It will be divided into 3 subgroups according to the energy used (monopolar, bipolar, laser energy).
* Group 2 (control): Conventional transurethral resection (n-120). It will be divided into 2 subgroups depending on the energy used (monopolar or bipolar).

A fact sheet will be given to the patient about the study and the signature of the informed consent will be requested in order to be included. The patient will be free to leave the study at any time without having to provide any justification and without affecting the treatment, intervention and follow-up that must be carried out.

The processing and storage of samples will be carried out in the pathological anatomy laboratory, according to standard clinical practice.

Patients will be monitored according to the usual clinical practice protocol (minimum 5-year follow-up), included in the non-muscle invasive bladder tumor protocols of the Puigvert Foundation.

En Bloc Bladder Tumor Resection: Prospective Randomized Study

En Bloc Bladder Tumor Resection: Prospective Randomized Evaluation of Monopolar, Bipolar and Laser Energy

Evaluation of muscle presence in the specimen

Bladder perforation grading, obturatory reflex, conversions to conventional TURB

Rate of planned postoperative single instillation of mitomycin/epirubicin

Post-operative complications according to Clavien-Dindo System

KARL STORZ Endoscopy-America, Inc.

Fundacio Puigvert

Chief of the Uro-Oncology Division and Kidney Transplant Unit

Symptoms and General Pathology

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy.

After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected.

The TURB will be carried out with bipolar current according to the traditional technique.

En bloc TURBT Collins Loop

emilio A ripalda, MD

Hugo Otaola Arca, M.D., Ph.D.

Manuel Álvarez Ardura, M.D.

Álvaro Páez Borda, M.D., Ph.D.

emilio f ripalda, MD

This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.

The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.

The secondary objetives are:

* Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications.
* Compare tumor recurrence after one year of follow up.
* Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx)
* Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding.
* Compare the degree of satisfaction of the surgeon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
En Bloc Bladder Tumor Resection: Prospective Randomized Study	NCT04712201	Urothelial Carc... Bladder Cancer	En bloc transur... Conventional TU...	18 Years -	Fundacio Puigvert
En Bloc Bladder Tumor Resection: Prospective Randomized Study	NCT04712201	Urothelial Carc... Bladder Cancer	En bloc transur... Conventional TU...	18 Years -	Fundacio Puigvert
En Bloc TURBT With Collins Loop vs Conventional TURBT	NCT05027412	Bladder Cancer Bladder Neoplas... Bladder Urothel... Bladder Cancer ... Urothelial Carc...	En bloc TURBT C... Conventional TU...	18 Years -	Hospital Universitario de Fuenlabrada
En Bloc Bladder Tumor Resection: Prospective Randomized Study	NCT04712201	Urothelial Carc... Bladder Cancer	En bloc transur... Conventional TU...	18 Years -	Fundacio Puigvert

Spots Global Cancer Trial Database for conventional turbt