Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

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

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The bladder tumour will be resected en bloc and removed in total, if possible.

The bladder tumour will be removed by conventional piecemeal resection.

Tumour is resected and removed from the bladder in one piece, if possible.

En Bloc resection

Conventional TURB

Jørgen Bjerggaard J, Professor MD

Ninna Kjær Nielsen, MD

Knud Fabrin, MD

Gitte W Lam, MD

Kasper Olsen, MD

Per Holt, MD

Juan Luis Vásquez, MD

Egils Vjaters

Karlis Kaufmanis

Erik Haug, MD

Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty.

Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed.

Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022.

Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.

Prevalence of detrusor muscle in specimen by pathological examination

Proportion of patients with recurrences at 4 months follow-up cystoscopy

University of Aarhus

Novo Nordisk A/S

Jørgen Bjerggaard Jensen

Professor, DMSc

Infections

Symptoms and General Pathology

Communicable Diseases

Diarrhea

Prostatic Hyperplasia

Hyperplasia

Signs and Symptoms, Digestive

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Bacterial Agents

Levofloxacin

Ofloxacin

Antibiotics, Antitubercular

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Koenraad van Renterghem, PhD

To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or \> 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or \> 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or \> 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Urosepsis, fever (t°\> 38.5) or epididymitis.

Jessa Hospital

Rare Diseases

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Doxorubicin

Liposomal doxorubicin

Vinblastine

Maximal and optimal TURB using a standardized procedure. The TURB will always try to be optically complete.

Neoadjuvant chemotherapy for 3 months with the intensified MVAC (6 cycles administered every 2 weeks): METHOREXATE: 30 mg/m2 D1 - VINBLASTINE: 3 mg/m2 D2 - ADRIAMYCINE 30 mg/m2 D2 - CISPLATINE 70 mg/m2 D2. + G-CSF: 5 µg/kg from D4 to D10 New maximal standardized TURB at the end of the chemotherapy. In case of a lesion localized at the bladder dome, and if a maximal TURB appears to be unsafe, a partial cystectomy without lymph node dissection will be performed.

The TURB will always try to be optically complete.

optimal TURB

Nicolas MOTTET, MD

Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma. But the removal of the bladder reservoir has a major impact of the Quality of life. Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in combination with an optimal transurethral bladder resection, in a strategy of bladder preservation, provided a complete response being obtained (about 50% in every trial using neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation rate at 5 years.

The feasibility and the efficacy of such an attitude in a multicentric trail using the most active regimen (in term of complete response in metastatic patients) is unknown. The chosen regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and vinblastine dose-intensity.

The efficacy and safety confirmation of such an approach could lead to consider it in patients motivated to retain a functional bladder.

Every patient having signed the inform consent will have the following steps Maximal and optimal TURB using a standardized procedure. The TURB will always try to be optically complete.

Neoadjuvant chemotherapy for 3 months with the intensified MVAC (6 cycles administered every 2 weeks): METHOREXATE: 30 mg/m2 D1 - VINBLASTINE: 3 mg/m2 D2 - ADRIAMYCINE 30 mg/m2 D2 - CISPLATINE 70 mg/m2 D2. + G-CSF: 5 µg/kg from D4 to D10 New maximal standardized TURB at the end of the chemotherapy. In case of a lesion localized at the bladder dome, and if a maximal TURB appears to be unsafe, a partial cystectomy without lymph node dissection will be performed.

If a complete response is obtained (no tumor cells in the bladder muscle on the last TURB), a surveillance will be proposed without any further treatment.

Otherwise (tumor cells in the bladder muscle at the second TURB), a radical cystectomy will be done.

If the balder is spared, the follow up will be as follow: clinical examination, CT, bladder endoscopy and urinary cytology every 6 months. The possible non muscle infiltrative bladder relapses will be treated according

Prospective Multicentric Evaluation of a Bladder Preservation Strategy

Prospective Multicentric Evaluation of a Bladder Preservation Strategy Using a Combination of Neoadjuvant Chemotherapy and Optimal Bladder Transurethral Resection in Patients With a Urothelial Carcinoma

Centre Hospitalier Universitaire de Saint Etienne

Anticonvulsants

Adjuvants, Anesthesia

Central Nervous System Depressants

Rocuronium

Neostigmine

Bromides

Glycopyrrolate

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Cholinesterase Inhibitors

Cholinergic Agents

Neurotransmitter Agents

Anesthetics

Muscarinic Antagonists

Cholinergic Antagonists

Participants to have cystoscopy with bladder tumor resection.

Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary.

Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.

Participants to have cystoscopy with bladder tumor resection.

Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary.

Neostigmine/Glycopyrrolate administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70 mcg/kg of Neostigmine with 14 mcg/kg Glycopyrrolate administered simultaneously over a period of one minute up to 5 mg.

Experimental: Sugammadex Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary.

Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.

Sugammadex

70 mcg/kg by vein to reverse the muscle relaxation.

14 mcg/kg by vein to reverse the muscle relaxation.

Farzin Goravanchi, DO

The goal of this clinical research study is to determine whether using sugammadex, given with a standard muscle relaxation drug during bladder surgeries, improves anesthesia conditions and recovery time.

During some bladder operations, your muscles must be completely relaxed. Muscle relaxation drugs cause the muscles to relax, including the respiratory muscles, and as a result artificial ventilation is needed to help you breathe. Sugammadex and other standard drugs reverse the effect of the muscle relaxation drugs, allowing you to breathe on your own after the operation.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:

* If you are in Group 1, you will receive sugammadex to reverse the muscle relaxation.
* If you are in Group 2, you will receive the standard of care (neostigmine/glycopyrrolate) to reverse the muscle relaxation.

You and the surgeon will not know which group you have been assigned to. However, the anesthesiologist and study staff will know.

Length of Study:

You will be on study for up to 1 week after the cystoscopy. If you are unable to have the procedure performed, you may be taken off study early.

This is an investigational study. Sugammadex and neostigmine/glycopyrrolate are all FDA approved and commercially available to reverse muscle relaxation. The comparison of these drugs is investigational.

Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.

Study Procedures:

Before the cystoscopy, we will collect your basic information and medical history. We will take your vital signs and the anesthesiologist will perform routine assessments. This will take about 30-60 minutes to complete.

Before the cystoscopy, you will be given rocuronium to relax your muscles. After the procedure, you will receive either sugammadex or the standard of care to reverse the relaxation.

After you are extubated (the tube is removed from your throat), we will assess how fast the relaxation drugs the anesthesiologist gave you wear off (stop working), using a small monitoring device that will be attached to your wrist. This is the only research test that will be done right after surgery.

If you are still in the hospital 1 day after the cystoscopy, a member of the staff will ask you the series of questions. If you have been sent home, you will be called and you will complete them by phone.

Researchers will also collect information about your cystoscopy procedure and recovery from your medical record. This collection will continue for up to 1 week after surgery.

Investigation of Sugammadex in Outpatient Urological Procedures

A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures

The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes.

To determine if Sugammadex can improve post-operative complications for outpatient bladder procedures such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications which was assessed uring follow ups on post-operative day 1 (POD1) and post-operative day 7 (POD7) looking for immediate postoperative complications such as bladder perforation, nausea, vomiting, postoperative intubation and hospital admittance secondary to respiratory complications and readmission within a week post-procedure for any other cause.

To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria.

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.

Suggamadex or Treatment Group

Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.

Neostigime/Glycopyrrolate or Standard of Care Group

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index (BMI)

Dr. Farzin Goravanchi / Anesthesiology & Perioperative Medicine

Muscle Recovery Time

PostOperative Complications

Overall Recovery Time

Overall Study

Urinary Tract Infections

Amikacin

Fosfomycin

Patients in the control group will receive amikacin as prophylactic antibiotic. It will be administered intravenously 30 minutes before procedure. Patients with an estimated glomerular filtration rate (EGFR) greater or equal than 70 ml/min will receive 1 gram of Amikacin. Patients with an EGFR less than 70 ml/min will received a calculated dose following the next parameters.

Patients with EGFR between 69-40 ml/min should receive: the calculated GFR x 0.18 = mg/kg.

Patients with EGFR less than 40 ml/min should receive: the calculated GFR x 0.36 = mg/kg.

Patients in the intervention group will receive Fosfomycin trometamol as prophylactic antibiotic. It will be administered orally in the night before procedure. Patients must be on fasting and will receive 3 grams.

Is the prophylactic drug which will be used in the intervention group.

Fosfomycin Tromethamine 3G Sachet

Is the prophylactic drug which will be used in the control group.

Ricardo A Castillejos, MD

Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and systemic postoperative infections such as urinary tract infection or surgical site infection. It should be recommended only when the potential benefit exceeds the anticipated risks and costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has been demonstrated, which frequently is incurred as an inappropriate selection of antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis.

The increase in multidrug resistance of antibiotics in recent decades has been associated with its misuse, resulting in an increased rate of morbidity and mortality, prolonged hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has increased its prevalence, a group of antibiotics widely used in urology. Therefore, local resistance patterns should be considered before following recommendations, especially in populations with poor control of antimicrobial use.

Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most common malignancy in the world. However, no recent randomized clinical trial has investigated antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is urinary tract infection (UTI), which is the most common healthcare related infection worldwide.

Under this premise, a randomized clinical trial is proposed to analyze the current panorama of UTI as a transcendent postoperative complication of TURB, under the context of the new emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good potential option for urological procedures due to its high activity against multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that guarantees wide tissue penetration and a high urinary concentration, in a single dose, the which will be compared with the control group with traditional prophylaxis (amikacin). The relative risk of UTI will be estimated, as well as the attributable risk of the main risk factors associated with this infection, allowing a better characterization of this population for adequate decision making regarding this clinical challenge.

In 1931, Stern and McCarthy created the first practical cut-out resectoscope, allowing endoscopic diagnosis and treatment of bladder tumors for the first time in history. From now on, TURB has been the cornerstone of the management of bladder tumors. Histological evaluation is essential for the precise classification and staging of this cancer, as well as the therapeutic modality of choice for most patients with bladder cancer

Epidemiology Bladder cancer is the most common malignancy of the urinary tract, being the seventh most common cancer in men and number 17 in women. The worldwide incidence is 9 per 100,000 men and 2 per 100,000 women. More than 75,000 new cases of bladder cancer are diagnosed in the United States of America annually, making bladder cancer the ninth most common malignancy of the urinary tract. In addition, bladder cancer is responsible for 15,000 annual deaths in the United States of America, which makes it the thirteenth cause of death in general and the second most common cause of death among genitourinary tumors

In Latin America, bladder cancer has an incidence of 5.6 per 100,000 inhabitants. Mexico lacks reliable records of cancer epidemiology, however, in Mexico it corresponds to 14.4% of genitourinary cancers, ranking as the fourth most frequent. Mortality in men is 3 per 100,000 and in women 1 per 100,000 with very high geographical variation due to unequal access to health services. In a second level hospital in Mexico City were reported 861 cases of genitourinary cancer, bladder cancer was accounted for 13%.

Urinary tract infection as a postoperative complication In urology, the act of instrumentation is a potential contributor of infection risk.

Before finalizing the TURB, a urethral catheter is placed to irrigate and wash the bladder three times with 100 mL of saline. At the end of the procedure, the bladder is completely drained and the function of the catheter is guaranteed to assess a subsequent irrigation in the postoperative period, for complications that may occur, such as haematuria or urinary retention due to obstruction of a clot and / or irrigation of intravesical chemotherapy. In the absence of complications, the catheter can be removed after 24 hours.

The risk of urinary tract infection is directly proportional to the duration of the catheterization, measured in days (catheter days) and the surgical time. It is reported a mean catheter day of 1.9 +/- 1.7 in 130 post-TURB patients. It is well known that urinary tract infection (UTI) associated with catheter use is the most common healthcare related infection in the world and is the result of widespread use of urinary catheterization. The incidence reported of UTI in the literature after surgery is 5-10%. Antimicrobial prophylaxis in TURB decreases the risk of UTI from 10.1% to 2.9%. In a series of 10,559 patients in the United States of America the incidence of UTI in post-TURB patients was 3 to 5%, being the most observed complication. The investigators concluded that as surgery time increased, urinary tract infection increased (2.8% in 0-30min to 5.4% in\> 90 min, P \<0.001).

In addition, a patient with cancer is a host with increased susceptibility to acquire infections. In the last 50 years the epidemiology of bacterial infections in cancer patients has presented a continuous change influenced by the nature and intensity of chemotherapeutic and immunosuppressive regimes and the widespread use of empirical and prophylactic antibiotics

Antimicrobial prophylaxis in TURB Surgical antimicrobial prophylaxis is the systemic administration of an antibiotic before, during and / or shortly after a urological procedure aimed to reduce the risk of local and systemic postoperative infections, such as urinary tract infection or surgical site infection. The optimal antimicrobial drug should be a microbiologically active agent against the most frequent potential pathogens and must have good pharmacological properties.

Antibiotics The antibiotics used for prophylaxis must be effective against the characteristic bacterial microbiota of the surgical site and relevant to the disease. In addition, it must be considered the properties of the antimicrobial agent, such as cost, convenience and safety. It should reach tissue serum levels that exceed the minimum inhibitory concentration for microorganisms characteristic of the surgical site, in this case Enterobacteriaceae and Enterococci. Moreover, it must have a long half-life to maintain sufficient serum and tissue concentrations throughout the procedure without the need to administer another dose. It must be safe, cheap and unlikely to promote bacterial resistance.

For the urinary tract, cephalosporins, fluoroquinolones and aminoglycosides are generally effective, have a long half-life, are cheap (when used as a single dose) and are rarely associated with allergic reactions. In addition, fluoroquinolones and aminoglycosides can be used in patients with a beta-lactam allergy. These antimicrobials can effectively cover the expected organisms and meet the criteria indicated above.

Current recommendations and the context in Mexico The American Urological Association (AUA) and the Japanese guidelines recommend the use of fluoroquinolones, trimethoprim- sulfamethoxazole, penicillins, first or second generation cephalosporins or aminoglycosides before the start of TURB as an antimicrobial prophylaxis. According to the guidelines of the Canadian Urology Association (CUA), any randomized clinical trials of antimicrobial prophylaxis in TURB were found, so the recommendations about antibiotic prophylaxis are based on other endoscopic urological procedures. Use of fluoroquinolone are recommended for prophylaxis before surgical procedure, also trimethoprim- sulfamethoxazole or third generation cephalosporins can be used.

In a study of TURB in 2006, the investigators used oral levofloxacin 200mg as prophylactic antibiotic, which was given 30-60 minutes before the procedure. However, in this context it would not be convenient to use this regime, because in a study conducted in 2015 specified that countries with poor control of the use of antimicrobials such as Mexico, there is a trend towards bacterial resistance, placing fluoroquinolones as the second line of treatment in urinary tract infection . An important cause of the emergence of these resistant strains is the excessive use (treatment when it is not needed and prolonged exposure to therapy) of antimicrobial agents for all indications.

Fluoroquinolone-based regimens, a pillar of prophylaxis guidelines, are increasingly ineffective due to a constant increase in multidrug-resistant gram-negative bacteria (MDR). The same concerns apply with second and third generation cephalosporins, which have resistance problems and, if administered orally, do not have a good penetration in tissues such as prostate.

Problem definition Since 2000 a serious global public health problem has arisen in relation to the increase in antimicrobial resistance, particularly among the pathogens of the ESKAPE group (Enterococcus faecium, Staphylococcus aureus, Clostridium difficile, Acinetobacter species, Pseudomona aeruginosa and Enterobacteriaceae), which are microorganisms that cause urinary tract infection. In addition to the increase in multidrug resistance to antibiotics and their misuse, this has been associated with an increased rate of morbidity and mortality, prolonged hospital stay and increased care costs.That's why antimicrobial prophylaxis is of such magnitude and importance that it needs to be updated to its reasoned use in order to improve its performance.

In the case of TURB, there is little evidence in the literature that recommends the use of preoperative antimicrobial prophylaxis in TURB, due to the lack of studies on this subject. The incidence of UTI in TURB has been reported between 2 to 39% and risk of infection in TURB from 18 to 75%.

Justification Nosocomial infection has been associated with an increased length of postoperative stays, rate of hospital readmission and the outpatient use of antimicrobial agents, which significantly increases the costs and use of medical resources.

Optimally, the specific prophylactic regimen should be supported by clinical trials evidence. In many cases, randomized clinical trials are not available. Such lack of data does not impede the adequacy of some antibiotic regimes based on the efficacy of the drugs, the cost, safety and knowledge of the microbiota of the surgical site. When selecting the antimicrobial for prophylaxis, the clinician should be aware of the different resistance patterns in the local community. Specifically, resistance to fluoroquinolones, which has increased their prevalence, therefore, should be considered due to the high use of these agents for antimicrobial prophylaxis in urological surgery.

Regarding the premise, "surgical antimicrobial prophylaxis is recommended only when the potential benefit exceeds the risks and anticipated costs," information on the costs associated with the prophylactic use of antimicrobials specifically for urological surgery cannot be easily obtained, however, data from other surgical disciplines can guide us in making decisions. For example, the use of prophylaxis in transurethral resection of the prostate, where there are multiple clinical trials and it is recommended the use of prophylaxis with pre-procedure third-generation cephalosporins. On the contrary, excessive and / or inappropriate antimicrobial prophylaxis increases costs, which can be reduced with measures to improve commitment with evidence-based recommendations. In general, the financial costs of prophylaxis are controlled using the least expensive and safest effective agent for the shortest time that is compatible with good clinical practice.

There are currently few randomized clinical studies (conducted more than 25 years ago) on the subject. In 1988 a randomized clinical trial was conducted with 243 patients undergoing TURB, three perioperative doses of cefradine were compared with placebo, observing a significant reduction in the rate of bacteriuria. However, no similar randomized clinical trials have been performed, as well as for other cystoscopic procedures that involve transurethral manipulation (bladder biopsy, ureteral catheterization, laser prostatectomy, etc.). For this reason, updated and available evidence is required for this widely used procedure.

The American Urological Association and the Japanese guidelines recommend the use of fluoroquinolones, trimethoprim, penicillins, first or second generation cephalosporins or aminoglycosides before the start of TURB as an antimicrobial prophylaxis In countries with poor control of the use of antimicrobials such as Mexico, there is a tendency towards bacterial resistance, placing fluoroquinolones as the second line of treatment for urinary tract infection. Therefore, the use of fluoroquinolone-based regimens, a pillar of prophylaxis guidelines, is increasingly ineffective due to a constant increase in resistant multidrug gram negative bacteria. The same applies with second and third generation cephalosporins, which also have resistance problems.

In 2007 a randomized clinical trial was performed and the effectiveness of fosfomycin against cefotiam to prevent infections associated with urological surgery was compared ,the response rates reported were 92.9% for fosfomycin and 94.9% for cefotiam in patients with transurethral surgery. Therefore, fosfomycin trometamol may be a potential option for urological procedures, due to its high effectiveness against resistant multidrug gram negative bacteria and its favorable pharmacokinetic parameters.

The aim of the study is to provide evidence to help clarify the usefulness and feasibility of antimicrobial prophylaxis, being fosfomycin trometamol an antibiotic that meets the necessary characteristics for this intervention. Therefore it will contribute to the characterization of the population that undergoes this procedure, which includes the description of risk factors and microbiological characteristics, such as the identification of emerging resistant strains. The results obtained will contribute towards the decision-making of this and other cytoscopic procedures due to the similarities in terms of invasiveness and possible tissue trauma, suggesting that the data regarding transurethral bladder resection can reasonably be extrapolated to other cystoscopic procedures with manipulation. The above will be compared with the antimicrobial prophylaxis that usually occurs in the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran which is based on aminoglycosides (Amikacin) administered in anesthetic induction before the surgical procedure.

Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)

Randomized Phase II Study of Antibiotic Prophylaxis With Fosfomycin vs Amikacin in Transurethral Resection of Bladder

Measurement tool: Urinalysis Measurement unit: Presence of nitrites in urinalysis: positive. Absence of nitrites in urinalysis: negative

Measurement tool: Urinalysis and microscopy Measurement unit: Presence of 0-5 leukocytes per field in urinalysis: negative.

Presence of 6 or more leukocytes per field in urinalysis: positive

Measurement tool: Urinalysis and microscopy Measurement unit: Presence of 0-2 erythrocytes per field in urinalysis: negative.

Presence of 3 or more erythrocytes per field in urinalysis: positive

Measurement tool: Interrogation and questionnaire Measurement unit: Use of antibiotics in the past 3 months before procedure: positive.

No use of antibiotics in the past 3 months before procedure: negative.

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Number of times the patient had a urinary tract infection before procedure.

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Patients had a urological surgery before procedure: positive Patient did not had a urological surgery before procedure: negative

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Patient had cystoscopy before procedure: positive Patient did not had a cystoscopy before procedure: negative

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Patient had urinary malformation before procedure: positive Patient did not had a urinary malformation before procedure: negative

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Patient had obstructive uropathy before procedure: positive Patient did not had a obstructive uropathy before procedure: negative

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Patient had vesicoureteral reflux before procedure: positive Patient did not had vesicoureteral reflux before procedure: negative

Measurement tool: Interrogation, questionnaire and clinical file review. Measurement unit: Number of times the patient had a transurethral resection of bladder tumor before procedure

Measurement tool: Interrogation and questionnaire Measurement unit: Use of intravesical chemotherapy before procedure: positive. Use of intravesical chemotherapy before procedure: negative.

Measurement tool: Interrogation and questionnaire Measurement unit: Use of intravesical chemotherapy before procedure: positive. Patient did not had intravesical chemotherapy before procedure: negative.

Measurement tool: Interrogation and questionnaire Measurement unit: Use of intravesical immunotherapy with BCG before procedure: positive.

Patient did not had intravesical immunotherapy with BCG before procedure: negative.

Measurement tool: Clinical manifestations of urinary tract infection plus positive urine culture.

Measurement unit: Colony-forming unit (CFU) per milliliter (mL) depending on how the urine sample was took. A positive urine culture will be confirmed using the next parameters: For midstream urine a count greater or equal to 100,000 CFU/mL and for urine obtained from a urethral catheter a count a count greater or equal to 100 CFU/mL Clinical manifestations of urinary tract infection: Patient presenting 1 or more of the following signs or symptoms: fever, dysuria, frequency, hematuria, lumbar pain, costovertebral angle tenderness)

Measurement tool: Positive urine culture and no clinical manifestation of urinary tract infection Measurement unit: Colony-forming unit (CFU) per milliliter (mL) depending on how the urine sample was took. A urine culture will be positive using the next parameters: For midstream urine a count greater or equal to 100,000 CFU/mL and for urine obtained from a urethral catheter a count a count greater or equal to 100 CFU/mL No clinical manifestations of urinary tract infection

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patients that presented a single tumor: positive Patients presenting more than 1 tumor: negative

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patients that presented 2 to 7 tumors: positive Patients that presented more than 7 tumors or a single tumor: negative

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patients that presented more than 7 tumors: positive Patients that presented less than 8 tumors: negative

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: milliliters

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patient with I ASA classification: Positive Patient with other ASA classification not being I: Negative

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patient with II ASA classification: Positive Patient with other ASA classification not being II: Negative

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patient with III ASA classification: Positive Patient with other ASA classification not being III: Negative

Measurement tool: Observation of the procedure and report of data collection sheet Measurement unit: Patient with IV ASA classification: Positive Patient with other ASA classification not being IV: Negative

Measurement tool: Observation of the procedure, report of data collection sheet and follow up note review Measurement unit: Patient with a urethral catheter removed 24 hours after procedure: positive Patient with a urethral catheter after 24 hours after procedure: negative

Based on the results of the histopathology report, the patients will be classified in nominal groups (non-muscle invasive bladder tumor, muscle invasive bladder tumor, chronic cystitis or other)

Measurement tool: Histopathology report Measurement unit: Patient with muscle invasive bladder cancer: Positive Patient with non-muscle invasive bladder cancer or chronic cystitis: Negative

Based on the results of the histopathology report, the patients will be classified in nominal groups (non-muscle invasive bladder tumor, muscle invasive bladder tumor, chronic cystitis or other) Measurement tool: Histopathology report Measurement unit: Patient with muscle invasive bladder cancer: Positive Patient with non-muscle invasive bladder cancer or chronic cystitis: Negative

Based on the results of the histopathology report, the patients will be classified in nominal groups (non-muscle invasive bladder tumor, muscle invasive bladder tumor, chronic cystitis or other) Measurement tool: Histopathology report Measurement unit: Patient with non-muscle invasive cancer: Positive Patient with muscle invasive cancer or chronic cystitis: Negative

Based on the results of the histopathology report, the patients will be classified in nominal groups (non-muscle invasive bladder tumor, muscle invasive bladder tumor, chronic cystitis or other) Measurement tool: Histopathology report Measurement unit: Patient with non-muscle invasive bladder cancer: Positive Patient with muscle invasive bladder cancer or chronic cystitis: Negative

Based on the results of the histopathology report, the patients will be classified in nominal groups (non-muscle invasive bladder tumor, muscle invasive bladder tumor, chronic cystitis or other) Measurement tool: Histopathology report Measurement unit: Patient with chronic cystitis: Positive Patient with non-muscle invasive bladder cancer or muscle invasive bladder cancer: Negative

Measurement tool: Observation of the procedure, report of data collection sheet and follow up note review Measurement unit: Number of days of urethral catheter after procedure

Laboratorios Senosiain, S.A. de C.V.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Urology Attending

Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB

Residents who have performed 10 to 30 TURBs.

Consultants with experience in the procedure defined as more than 100 TURBs.

It is not a randomized trial - all three groups are exposed to simulation training.

Simulation training

Bladder cancer (BC) is the seventh most common cancer in men worldwide and fourth most common cancer among Danish men. BC is estimated to be the most cost expensive cancer pr. patient life. BC is diagnosed, staged and if possible treated with a transurethral bladder tumor resection (TUR-B).

The prognosis of BC is depending on the depth of invasion, which makes the quality of the TURB procedure of utmost importance. Retrospective studies from Sweden and Canada on resident involvement in TURB procedures indicated that the TURBs were insufficient with regard to staging and had a higher need of repeating TURB.

Surgical training for TURB in Denmark today is based on the Halstedian principle: "See one, do one, teach one", comparable to training in Sweden and Canada. Thus, there is a need to develop better and safer principles for training.

Simulators for surgical procedures have a promising role in the surgical training. The project will explore the effect of simulation training on the quality in transurethral resection of bladder tumors.

Based on our findings the principles of simulator training will be integrated in a curriculum for simulator-based TURB training for urological surgeons in Denmark.

The collaboration research group is composed of medical doctors in urological surgery at Urological Department at Zealand University Hospital, Roskilde (ROS) and experts in medical simulation at Copenhagen Academy for Medical Education and Simulation at Rigshospitalet (CAMES).

The incidence of bladder tumors is increasing and is more than 2,000 in Denmark. The bladder tumor is initially treated by transurethral resection (TURB) classifying the tumor by debt of invasion. The bladder wall is composed of urothelium, lamina propria and muscularis propria also known as the detrusor muscle. Bladder cancer (BC), defined as detrusor-muscle invasive tumors, are found in approximately 50% of bladder tumors. BC is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in men in Denmark. Superficial bladder tumors can be treated with TURB whereas BC is treated with radical cystectomy. Thus, it is of utmost importance that TURB is done with sufficient resection of the detrusor muscle to ensure that the patient is staged correctly to optimise treatment.

TURB was first described and performed by Desormeaux in 1867 and the obstacles for the surgeon remain the same more the 150 years after. TUR-B demands haptic skills, the ability to identify the layers of the bladder wall, the ability to perceive the stiffness of the tissue through radial and tangential movements and the ability to translate two-dimensional pictures to a three-dimensional understanding and at the same time move surgical instruments around an axis.

As TUR-B is performed through the urethra with one scope only, the learner is left with observation of the master until the day occurs where the learner is trusted the scope. Thus, the gap between seeing and doing TURB remains significant.

The outcome of TURB have been shown to be dependent on surgeon-experience, with a higher risk for insufficient resections with lower surgeon experience. A recent Canadian study from a single centre showed that resident involvement in TUR-B had fewer complete resections including the detrusor muscle layer in the pathological specimen and patients had delayed time to cystectomy when compared to patients who had the TUR-B performed by attending urologists. Thus, both patient safety and quality of care are compromised when residents are involved in the treatment and staging of patients with bladder tumors.

The current education in TURB in Denmark is based on classical apprenticeship as it has been for the last 150 years, with the resident learning from a supervisor while performing TURB on patients.

Needs assessment analyses among specialists in urology and medical education in Denmark in 2017 identified TURB as a procedure in which simulation based skill acquisition are desired.

Simulation-based training is increasingly used in medical education. The opportunity to train a procedure repeatedly in a secure, stress-free environment with several different scenarios is appealing. Even though simulation-based training carries these promising opportunities, the challenge, when introducing simulation-based training, is to identify if the training transfer to actually improved performance on patients. Thus, we need to test if the simulator training leads to a level of minimum competency before progressing to performance on patients. A minimum passing standard should not be defined by amount of training, but by simulator performance outcomes.

Thus, we need to define test outcomes that identify competency before introducing a simulation-based test. Mastery learning (ML) is an educational theory in which the learner is to train until reaching a minimum acquisition level. The endpoint of the training is hereby a predefined competency level, and not an arbitrary amount of training hours. In the light of the ML framework the principle of directed self-regulated learning (DSRL) has evoked. DSRL is a learning-approach where the student regulates his/her own progress through a defined training protocol without guidance from an instructor. The theory is that this approach provides the student the opportunity to develop own strategies and to learn from mistakes, while also increasing the availability of training independent of supervision from a busy faculty.(20) DSRL can be modified to ensure that the learner do not learn unappropriated methods by either written theoretical material, video instructions, a non-expert assistant or all of them. Thus, the purpose of this trial is to develop and gather validity evidence for a simulator-based test in TURB based on the principles of ML and DSRL.

Hypothesis Overall: A simulator-based test can identify competency-levels with regard to a score based simulator metrics.

Aim of project To develop and gather validity evidence for a simulator-based test in TURB.

Research Question

* Can the test discriminate between varying competency levels?
* Can we establish a level of competency by a test in simulator-based TURB training?

Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors

Based on simulator metrics with significant discriminatory ability between different experience levels, a test score is constructed.

Copenhagen Academy for Medical Education and Simulation

Rigshospitalet, Denmark

MD, Ph.D. student

Patients with suspected bladder cancer underwent multiparametric magnetic resonance imaging (mMRI) and vescical imaging reporting and data system (VI-RADS) score calculation. After trans-urethral resection of bladder (TURB), the results of biopsy were compared to the VI-RADS score to verify their concordance.

VI-RADS

Sara Cecchini, MD

VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

The VI-RADS (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (TURB). The VI-RADS consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. VI-RADS was an observational, prospective, multicenter, no profit study. The aims of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location

The sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in muscle invasion will be evaluated by comparing the score of VI-RADS with the results of biopsy after transurethral resection of bladder cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer	NCT05223491	Non-muscle Inva...	En Bloc resecti... Conventional TU...	18 Years -	Aarhus University Hospital
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)	NCT04212403	Urosepsis Bladder Cancer Prostate Hyperp... Antibiotic Resi... Antibiotic Resi... Antibiotic-asso... Antibiotic Toxi...	Levofloxacin	18 Years -	Jessa Hospital
Prospective Multicentric Evaluation of a Bladder Preservation Strategy	NCT01093066	Urothelial Carc...	optimal TURB	18 Years - 69 Years	Centre Hospitalier Universitaire de Saint Etienne
Investigation of Sugammadex in Outpatient Urological Procedures	NCT03138967	Malignant Neopl... Bladder Cancer	Rocuronium Sugammadex Neostigmine Glycopyrrolate	18 Years -	M.D. Anderson Cancer Center
Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)	NCT04209192	Urinary Tract I... Bladder Cancer Urologic Surgic...	Fosfomycin Trom... Amikacin	18 Years -	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors	NCT03863028	Validity-eviden... Virtual Simulat... Bladder Cancer Surgical Skill ... Medical Educati... Transurethral R...	Simulation trai...	-	Rigshospitalet, Denmark
Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors	NCT03863028	Validity-eviden... Virtual Simulat... Bladder Cancer Surgical Skill ... Medical Educati... Transurethral R...	Simulation trai...	-	Rigshospitalet, Denmark
Investigation of Sugammadex in Outpatient Urological Procedures	NCT03138967	Malignant Neopl... Bladder Cancer	Rocuronium Sugammadex Neostigmine Glycopyrrolate	18 Years -	M.D. Anderson Cancer Center
Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location	NCT06337591	Bladder Cancer	VI-RADS	-	Istituto Nazionale di Ricovero e Cura per Anziani

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Spots Global Cancer Trial Database for turb

Every month we try and update this database with for turb cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for turb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.